Validation Engineer Salary in Connecticut, USA

Are you ready to join Connecticut Innovation's vibrant community of innovators? Connecticut Innovations ("CI") is Connecticut's strategic venture capital arm, and we are passionate about serving our portfolio of 220+ companies across various industries, with strengths in life sciences, technology, and climate tech. Come join one of our quickly growing portfolio companies, Enko!At Enko we believe that to create the future the world wants, we need to change the way the world grows. Our goal is not just to create something better, but to play a part in something bigger. Enko discovers and develops novel products for farmers to protect their crops from pests and disease.Our agricultural invention platform, Enkompass™, uses A.I. and machine learning to create more effective ways of finding and selecting the right treatments for the right targets. Led by a team of proven scientists, entrepreneurs, and industry veterans, Enko's innovative science, agile design, and discovery of new modes of action is producing next-generation crop protection solutions that will overcome the critical challenges facing industry. The industry has taken notice, and we have active projects with many key industry players...with more to come!Enko is searching for a highly collaborative, solutions-oriented Software Engineer to join their quickly growing computational science team to specifically to help build unique datasets, AI models, and the infrastructure to support them.What You'll DoYour main objective will be to develop internal tools, data products, and infrastructure that will enhance the productivity of our small molecule discovery pipeline. You will be a key contributor to the direction and execution of our software infrastructure, and to making technical decisions that advance our AI and data products. You will have influence in the continued development of a culture of innovation and empowerment as a valued technical expert.This will be a hybrid role, at our HQ and research facility in Mystic, CT. The successful candidate must be very comfortable working in a fast-paced environment with demonstrated ability to juggle competing tasks and demands. This role represents a great opportunity to utilize scientific, technical, and interpersonal skills:Build software tools to support the Company's computational chemistry efforts including molecular design, chem informatics, AI-based predictive systems, simulation and virtual screening.Architect cloud infrastructure for handling large datasets and computational needs efficiently and easily.Apply expertise to enable training and validation of machine learning models using data from multiple sources, including DEL screening experiments, to rapidly and cost effectively discover and optimize chemistries.Collaborate closely across the company to explore ways to accelerate the discovery and development of novel small molecules aligned with the company's strategic goals.About YouYou hold an advanced degree in a STEM discipline.You have a minimum of 3 years of post-degree experience in a lab environment or related industry.You have previous Individual contributor experience in both data engineering and machine learning engineering for deep learning models, preferably in a scientific application.You care about building clean code and are passionate about continuous development of your technical skillset. You have previously written test scripts and SQL queries.You have experience building and maintaining scalable APIs.You possess the ability to move beyond packaged software to prototype and implement innovative ideas.You love to build relationships and have an eagerness to collaborate across disciplines and quickly learn new domain knowledge. You are inquisitive and believe that broad curiosity helps to generate process improvements. Why Work at Enko?Our products address a $70 billion core market focused on crop health with expansion into adjacent markets worth $300+ billion.We have $150 million in capitalization, with $80 million raised as part of a Series C in December 2022 Our global investors include Anterra Capital, Nufarm, the Bill & Melinda Gates Foundation, Eight Roads Ventures, Finistere Ventures, Rabo Food & Agri Innovation Fund, Novalis LifeSciences, Syngenta, TaherGozal, Germin8 Ventures, TO Ventures Food, Endeavor8, Connecticut Innovations, Silver Blue LLC, and Alumni Ventures Group.We have over 40 novel pipeline programs and 5 strategic partnerships announced, including with Syngenta and BayerOur headquarters and research facility in Mystic, CT has 90,000 square feet of state-of-the-art labs and computer-controlled greenhouses built for pre-field experimentation and scale.Enko is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Careers that Change Lives Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results...the right way and Put Patients First. That's the Medtronic Mindset - our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.A Day in the Life The Manufacturing Engineer II is a key Operations representative within the North Haven Shared Service Engineering Group. This person will collaborate on project teams to develop high quality, high reliability, and highly manufacturable medical devices for Medtronic. They will also support the maintenance of business for labeling systems across the 4 Focus Factories.General responsibilities include: Conduct engineering studies to support process validation and contribute to maximizing production performance. Provide engineering support for equipment development, assembly methods and process validation of new and existing products. Manufacturing process evaluation, product troubleshooting and support of in-house manufacturing products and processes Collaborate on project teams to develop high quality, high reliability, and highly manufacturable medical devices for Medtronic. Work under the direction of the Engineering Manager in a fast-paced collaborative environment supporting program initiatives and compliant initiatives with company best practices. Essential functions: Contribute to continuous improvements in overall product cost and quality. Participate in DFM / DFA activities assuring that production processes / equipment is taken into consideration. Maintain documentation associated with manufacturing processes. Provide technical support for production tools including applied automation. Follow established guidelines and management direction with regards to good engineering decisions Advise leadership of developments which may affect profit, schedule, and costs. Participate on projects to concurrently develop assembly methods, tooling, equipment, and processes for new and existing products. Partner with Manufacturing to develop lean principals to implement solutions for product assembly. Create standardized work charts, work combination tables and process maps that result in an optimized production system and extended value stream. Support project team members in achieving business including attainment of Safety, Quality, Service, and Project Schedule and Cost goals. Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities. Daily interaction with manufacturing providing hands-on support and responsibility for metrics such as labor time, lead-time, capability, and yield. Provide detailed engineering analysis and documentation in the management of material disposition, process updates, ECR's and CAPA. Support manufacturing implementation and facility transfer while providing technical support to receiving facility. Complete on time project updates, project hours, development plans, self-assessments, and successful completion of all training requirements. Responsibilities may include the following and other duties may be assigned. Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Design arrangement of machines within plant facilities to ensure most efficient and productive layout. Design sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapt machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develop manufacturing processes that are applicable to statistical process control and may develop those techniques. Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensure processes and procedures are in compliance with regulations. Must Have: Minimum Requirements Bachelors degree required Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience Nice to Have BS or MS Engineering or equivalent Two-to-four-year applicable experience Demonstrated knowledge of DFA, PFMEA, Validation IQ / OQ / PQ. Strong Project Management skills. Strong communication, manufacturing process, product industrialization and leadership skills Dynamic, positive attitude Solid design, troubleshooting and presentation skills Knowledge of Lean and/or 6 Sigma, GD&T, DFMEA and PFMEA Electrical controls and automation experience. Knowledge in the application of machine motion controls, servo and pneumatic. Knowledge of electrical, pneumatic and machine guarding safety standards. Experience in equipment risk assessments and mitigation plans. Experience in Lean Design and Manufacturing. Knowledge and experience with material processing and testing Engineering and Problem-solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United Stat es of America)

This is what you will do:This position will serve the role of Engineer II for device development / human factors engineering within the Alexion Device Development organization. The role will support the human factors workstreams for pipeline products as well as lifecycle management. This role will interact with multiple functional teams including Device Development, Clinical, Commercial/Marketing, Quality, and Regulatory, clinical development through registration and commercial product support. You will be responsible for:Lead and support activities under the human factors and usability engineering process for combination product design and development from feasibility, clinical development through registration and post-market.Support core teams to develop and support the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products.Support design validation activities including summative human factors study (i.e. human factors validation) from protocol development, study execution, and reporting.Provide input for user need identification and user interface specifications development.Author use-related risk management activities such as known use problem analysis, hazard analysis, and use-related risks analysisDraw learnings from competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging) Interface with human factors firms (vendors) and manage their activities for a formative or summative human factors study.Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.Ensure all human factors engineering activities as required and comply with the Company's quality assurance requirements as well as applicable regulatory requirements.Support feasibility activity of device assessment (e.g., testing, fixturing, protocol, report).You will need to have:Experience in human factors engineering and exposure to design and development of medical device and combination products.Awareness of design control activities .Ability to manage external human factors firms (vendors).Strong communication and collaboration skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations.Knowledge of human factor/usability engineering, safety, performance and regulatory compliance requirements of medical device and combination products (e.g. IEC 62366, FDA HF guidances, EU Regulation 2017/745 (MDR)).[For office-based positions:] As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have:Bachelor's or Master's degree in Engineering (Biomedical, Chemical, Mechanical, Electrical Engineering or Human Factors) plus 0-3 year experience in medical device Human Factors development. Experience with injection based combination product development and risk management preferred. Experience with graphics design a plus.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do: This position will lead research, design and implement scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. Develop a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred.The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, will support deviation investigations, change controls, and CAPAs using electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and in-person on-site manufacturing support. Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.You will be responsible for: Own the design and implement studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sitesLead progression of projects with multi-functional collaborators, as well as understand the implications of project activities and decisions with minimal directionPrioritizing multiple tasks and projects independently and as part of the teamAuthor SOPs, study protocols and technical reportsParticipate in multi-functional development teams representing Injectable Drug Product DevelopmentMaintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Train other peers as assigned in areas of expertiseActively participate in department and team meetings including assuming ownership and delivering on assign action itemsDevelop presentations for meetings with internal and external partnersYou will need to have:Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 4+ years of relevant experience or Master's degree with 3+ years of relevant work experienceDedicated initiative to find resolution for technical challengesExcellent interpersonal, collaborative and communication skillsThe duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Scientific and practical knowledge of protein biochemistry and/or drug product process developmentPrevious experience in bio-therapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLAScientific understanding of protein stability, thermodynamics, mechanism of protein degradation, bio-therapeutics drug formulation development and analytical tools used to test formulations is a plusHigh level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPointExpectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do: This position will lead research, design and implement scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. Develop a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred.The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, will support deviation investigations, change controls, and CAPAs using electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and in-person on-site manufacturing support. Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.You will be responsible for: Own the design and implement studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sitesLead progression of projects with multi-functional collaborators, as well as understand the implications of project activities and decisions with minimal directionPrioritizing multiple tasks and projects independently and as part of the teamAuthor SOPs, study protocols and technical reportsParticipate in multi-functional development teams representing Injectable Drug Product DevelopmentMaintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Train other peers as assigned in areas of expertiseActively participate in department and team meetings including assuming ownership and delivering on assign action itemsDevelop presentations for meetings with internal and external partnersYou will need to have:Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 4+ years of relevant experience or Master's degree with 3+ years of relevant work experienceDedicated initiative to find resolution for technical challengesExcellent interpersonal, collaborative and communication skillsThe duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Scientific and practical knowledge of protein biochemistry and/or drug product process developmentPrevious experience in bio-therapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLAScientific understanding of protein stability, thermodynamics, mechanism of protein degradation, bio-therapeutics drug formulation development and analytical tools used to test formulations is a plusHigh level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPointExpectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!Date Posted26-Apr-2024Closing Date30-Jul-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This is what you will do: This position is responsible for leading research, design and execute scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. The candidate will support the development of a variety of manufacturing unit operations including, but not limited to, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred. The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, including but not limited to sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, the candidate will support deviation investigations, change controls, and CAPAs utilizing electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and as necessary in-person on-site manufacturing support. This position is expected to interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA. You will be responsible for: Lead the design and execute studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites Lead progression of projects with cross functional stakeholders, as well as understand the cross functional implication of project activities and decisions with minimal supervision Prioritizing multiple assigned tasks and projects independently and as part of the team Contribute to the development of strategic project plans for molecules in clinical development Author SOPs, study protocols and technical reports with minimal supervision Participate in cross-functional development teams representing Injectable Drug Product Development Maintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Actively participate in department and team meetings including assuming ownership and delivering on assign action items Develop presentations for meetings with internal and external stakeholders with minimal supervision Mentor and train junior Associate Scientists and Engineers regarding drug product development You will need to have: Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 7+ years of relevant experience or Master's degree with 6+ years of relevant work experience Self-driven initiative to find resolution for technical challenges Excellent interpersonal, collaborative and communication skills The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Scientific and practical knowledge of protein biochemistry and/or drug product process development is preferred Previous experience in biotherapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLA is preferred Scientific understanding of protein stability, thermodynamics, mechanism of protein degradation, biotherapeutics drug formulation development and analytical tools used to test formulations is a plus High level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint In-person statement for 4 days in the office:When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do:The position will lead technical transfer of early and late clinical phase drug substance, to both internal and external contract development & manufacturing (CDMO) companies. This position will provide strong scientific leadership, mentorship and subject matter expertise for all aspects of drug substance including technology transfer, process fit analysis, process modelling, raw material controls and aseptic process assurance/microbiological control. The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), non-GMP internal Pilot network, Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Manufacturing sites.Other areas of responsibility include technical support for ongoing clinical manufacturing, process troubleshooting to manufacturing activities such as supporting process related investigations, deviation resolution, corrective actions/preventative actions, and direct responsibility for process monitoring/control charting of manufacturing operations. Review of technical documents and support for regulatory submissions (IND/IMPD, BLA/MAA) are other responsibilities.You will be responsible for: Manage and lead clinical technical transfer process and ensure alignment with CMC schedule to meet program and company goals / metrics, as required. This includes continuous communication with Quality Assurance, Quality Control, Upstream and Downstream Process Development, Drug Product Development, Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's clinical drug substance manufacturing activities.Provide technical leadership and oversight for internal and external technology transfers, and process development, where requiredLead technical evaluation and contribute to selection of external manufacturing facilities for drug substancePerform facility fit analysis, process gap assessments, and establish operational control strategy for each new receiving siteLead efforts to assess readiness for early and/or late phase transfers using appropriate tools and manage risk communication with leadership along with proposed mitigation/sLead creation and/or technical review of batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Alexion operations as applicableEnsure appropriate data management, perform process monitoring and communicate operation status to management. Provide technical depth and lead OOT and deviation investigations as requiredServe as Drug Substance Team Lead, including representation at CMC asset team, to support late-stage pipeline programs through validation campaigns and initial commercialization, as requiredIdentify issues and risks and lead cross functional team to identify and drive alignment on action/mitigation plan for path forwardLead continuous improvement of efficiency of technology transfer plans and work process and influence manufacturing sites to focus on improving efficiency of technology transfer processesFoster collaboration of all cross-function and external partnersManage and develop matrix team providing opportunities and actively supporting career enhancement and growthCo-author and review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissionsGlobal role requiring domestic and international travel (up to ~20%)You will need to have:PhD in biochemistry, biological science, or chemical engineering or related fields with 6+ years of relevant experience, or BS/MS with 10+years of relevant experience in biopharmaceutical organization with expertise in drug substance development and/or tech transferPassport and ability to travel domestically and internationally for manufacturing site supportDuring travel for manufacturing support, this role requires physical capabilities to gown and don PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Intellectual capabilities include engaging in problem solving and non-linear thought, analysis, and dialogue, collaboration with other peer functional representatives.Technical services experience for discrepancy resolution, CAPA implementation and process data monitoring for internal and external facilitiesUpstream or downstream manufacturing of monoclonal antibodies/therapeutic proteins with lab and pilot plant operations (non-GMP/GMP)Demonstrated Understanding of technology transfer, process fit analysis and clinical phase appropriate process oversight and control, with expertise in late phase technology transfer and validationcGMP/ICH requirements for clinical and commercial biopharmaceuticalsAbility to present and defend technical aspects of manufacturing operations during regulatory agency inspectionsAbility to influence others without authority, including external partners, and communicate with all levels of the organizationStrong project leadership and resource management skills along with good verbal and interpersonal skillsAbility to support development of bold but achievable project plans to ensure effective, timely execution!We would prefer for you to have:Knowledge in planning for program advancement to process validation and commercial launch, with experience supporting teams through BLA approvalsExpertise in CFD modeling, raw material or microbiological control strategyCapability to analyze data using basic statistical methods, and present comparability analysis in evidence of effective transferKnowledge of quality attribute measurement assays and application to troubleshooting product quality related discrepancies.Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

At HED, Inc. we are customer focused, respectful, passionate, collaborative, and agile - guided by our mission to create innovative quality products that make a difference when it matters, enabling a better, safer, connected world. Our people understand the velocity at which our hi-tech markets change, ever driving the need for curious, future oriented teammates to help us continuously improve our processes, products, and service. Accountable to ourselves, each other, and our customers, because we understand our success depends on world class products and service delivered on time by an empowered and engaged team. We share success with continued learning, rewards, recognition, flexibility, and celebrations. Proud of what we do and how we do it.We are one team, one voice, one outcome and we are looking for a Mechanical Engineer II or Sr. to join us and help make a difference when it matters!As a Mechanical Engineer, you are responsible for designing and developing components and assemblies to meet or exceed customer (internal/external) established requirements across all parts of the product development lifecycle (from authoring requirements to development, test, and product sustainment). If you enjoy the challenge of a growing organization, and want to make a difference when it matters, we would love to hear from you. Salary commensurate with experience.ESSENTIAL DUTIES and RESPONSIBILITIES:-Design and develop mechanical components and end products utilizing state-of-the-art mechanical engineering techniques to meet or exceed design and performance requirements established by internal and/or external customers.-Test and Analyze: new product and existing product performance with written report of results.-Recommend design modifications to improve either customer and market acceptance or to accommodate changes in customer requirements.-Coordinate with engineering staff for support activities required to complete projects as scheduled.-Maintain proper time reporting, progress reviews and project updates as required.-Supports verification and validation testing of new and existing products.-Help establish and support a project plan and schedule to meet and achieve project deliverables as defined by the Project Manager.-Ensure Product compliance to industry standard specifications of components, assemblies and/or sub-assemblies, as required.-Use computer aided engineering/design software tools and equipment to perform engineering tasks, including component drawings, tool design, industrial design, simulation, and analysis (experience working in a SolidWorks environment is a strong plus).-Lead and/or participate in design reviews on new designs.-Designs using analytical means to calculate and predict performance.-Perform root cause investigation and analysis of field returns as needed.-Participate in sustaining engineering to find alternate components and production support.-Create and maintain product documentation: Bills of Materials (BOM), Specifications testing requirements, Change notices or deviations.-Write reports, letters, comprehensive design proposals and progress reports. -Effectively present information orally and in writing to technical and managerial personnel and to small groups-If necessary, will travel to the customer's site, to commission and/or troubleshoot products. This may involve travel by plane and/or automobile and may include overnight stays.-Collaborate with Electrical Design Team on packaging of electronic-based assemblies, including thermal management and FEA considerations.-Work with Test Engineer for product verification and validation testing.-Collaborate with Operations, Project management and Business Development for engineering changes and deviations. -Provide assistance to Business Development in developing formal responses to customer requests for product quotations (RFQ).-Partner with Quality Assurance to resolve any product related reliability issues and drive root cause and corrective actions for field returns.-Direct out-sourced vendors as needed.-Assist with the transition of prototype hardware to Production.-Provide assistance and technical expertise as required by the customer.-Other duties as assigned by the Lead or Manager. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.MINIMUM QUALIFICATIONS:Education:BA/BS in Mechanical Engineering or similarExperience and Knowledge:Minimum 3-7 years of production, electronic/mechanical product development, SolidWorks, AutoCAD, and electronic/mechanical trouble shooting experience.Design experience with plastic injection molding and sheet metal forming.Design experience with electromechanical assemblies including PCBs and wire harnesses.FEA Analysis experience.Creating assembly drawing for manufacture.Must have proven ability to design components, assemble prototypes, test the product, and generate complete documentation. Experience with various fabrication techniques including additive manufacturing. (3D printing) ASME / ISO / Automotive standards.Product performance verification testing. Ability to write technical reports and comprehensive design proposals.Ability to estimate engineering hours and resources for assigned project activities.Proficient with Microsoft Office tools (e.g., Word, Excel, PowerPoint).Good verbal and written communication skillsDemonstrated ability to interface successfully with customers, influence others and excel in a matrix environment. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Ability to participate in and influence cross-functional teams.PREFERRED QUALIFICATIONS:Vibration modal analysis experience.Thermal simulation analysis experience.PHYSICAL AND MENTAL DEMANDS:While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. Specific vision abilities required by this job include close vision and the ability to adjust focus. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.WORKING ENVIRONMENT:Work is performed in an office environment or at customer sites when travelling. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Client: HealthcareJD:Collaborate with cross-functional teams to understand ETL requirements and specifications.Experience in Healthcare - Clinical domain - CCDA, HL7 & FHIR data testing experienceDesign, develop, and execute ETL test cases and scenarios to validate data accuracy, transformation, and integration across systems.Perform data validation and reconciliation between source and target systems.Identify, document, and report defects and anomalies in ETL processes and data flows.Develop and maintain test data sets for ETL testing purposes.Perform performance and scalability testing of ETL processes to ensure optimal performance and efficient data processing.Utilize ETL tools(Informatica or Optim), GCP/AWS services, Snowflake, and Teradata to conduct testing activities.Participate in the design and implementation of testing frameworks and methodologies to improve testing efficiency and effectiveness.Collaborate with developers, data engineers, and data analysts to understand data structures and mappings.Conduct root cause analysis and collaborate with teams to address and resolve ETL-related issues.Keep up to date with industry best practices and emerging technologies in ETL testing, AWS, Snowflake, and Teradata.Prior automation exposure will be given priority - Selenium (java or python)Qualifications :Proven experience as an ETL Tester or Data Quality Analyst.Strong hands-on experience with ETL testing tools and methodologies.Proficiency in using ETL tools such as Informatica, Talend, or similar.Solid understanding of AWS services / GCP related to data integration and storage.Experience working with Snowflake / Teradata databases.Knowledge of SQL and data querying for validation purposes.Familiarity with data warehousing concepts and data modeling.Strong analytical skills and attention to detail.Excellent communication and collaboration skills.Ability to work in an Agile development environment.GCP or ETL certification is a plus.

Job Title: Space Vehicle Software Systems Engineer (Active TS/SCI Security Clearance Required)Job Code: 10696Job Location: Remote or Palm Bay, FL or Rochester, NY or Ft. Wayne, IN or Colorado Springs, CO or San Diego, CAJob Description: L3Harris' Space and Airborne Systems seeks a Space Vehicle (SV) Software Systems Engineer (SWSE) to join our growing team. The individual in this position will serve as the lead software systems engineer for integrating numerous software CSCIs across the spacecraft bus, mission payload, and communications payload to ensure seamless end-to-end mission performance when interfacing Ground, Operations and Test SW CSCIs. The SWSE has overall technical responsibility for the software design, development, integration, and test for the Space Vehicle and serves as the primary software point of contact for external segments, test and operations. The SWSE will coordinate and/or perform test and analysis integration activities to ensure the system meets Customer and Mission requirements. The SWSE will coordinate all software technical efforts to generate contractually required system design documents and design review technical packages. Essential Functions: Manages and maintains integration of SW & FW w/ HW across all aspects of the SV and according to internal and external ICDsGeneration and coordination of software design specifications and interface (internal and external) documents including requirements derivation, allocation, and flow up/down, and V&V activitiesExtracts software requirements from mission-level and CONOPs, and cascades them to the spacecraft bus, mission payload, and communications payload, encompassing allocations into software, firmware, and hardware, as well as test beds and simulators.Ensures electrical functional and physical allocations, changes and requirements compliance are being addressed throughout the SV design.Coordinates and/or completes integration activities such as processor/memory utilization, data sizing, etc.Supports the SEIT organization in planning the integration testing of HW/SW from the subsystem level to the SV level, including execution of SV level tests and troubleshooting issuesMaintains cognizance and communicates changes of the SV subcontractor and in-house Firmware and Software baselines. Support to the system modeling teams in generation of Cameo system views and simulations as well as ConOps generationWorks closely with Electrical, Mechanical, and Integration and Test Systems Engineers to own and oversees End-to-End integration of spacecraft bus, mission payload, and communications payload across the full program lifecycleRepresent Space Vehicle software engineering during major system level design reviews such as SRR, SDR, PDR and CDR and milestone reviews such as MRR, TRR, PSF, LRR and MDRLeads or participates in failure review boards, engineering review boards, change control boards to ensure software impacts are coordinated across the SVCreating and/or supporting delivery of Customer CDRLSAbility to lead diverse technical teams across internal and subcontractor efforts25% travel as requiredQualifications: Bachelor's Degree and minimum 9 years of prior relevant experience. Graduate Degree and a minimum of 7 years of prior related experience. In lieu of a degree, minimum of 13 years of prior related experience.Bachelor's Degree in Software Engineering, Systems Engineering, or adjacent field.Active TS/SCI security clearance. Experience with integrated Space Vehicle Software CSCIs for seamless end-to-end mission performance.Experience with leading both internal and external supplier software engineering teams.Experience with Software/Hardware integration, testing, and troubleshooting of complex systems.Preferred Additional Skills: Well versed in fleshing out physical and functional interface details such as software and communication protocols, data rates, data formats, data and bit structures, application programming interfaces (API), and error handling mechanismsExperienced with software requirements validation, sell-off, milestone entry/exit criteriaExperienced with software integration planning when there are multiple SW/HW solutions in the loopExperience with writing Statement of Works for external and internal suppliersFamiliarity with SW engineering processes such as Agile/Waterfall, DevSecOps, Cont Integration as well as SW development related to embedded/RT/architecture patternsFamiliarity with Digital Engineering and MBSE tools such as DOORs, CAMEO, CREO, JIRAStrong track record of leading software engineering teams through all phases of a space program; pursuits and proposal, design and development, integration and test, and operationsAbility to make risk-based decisions balancing technical, cost and scheduleAbility to perform Space Vehicle software analyses and trades such as processor and memory utilization, data sizing and flows, fault management techniques, etc.Experience in mentoring and growing technical staffIn compliance with pay transparency requirements, the salary range for this role is $106,500 - $197,500. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements. The application window for this requisition is anticipated to close July 31, 2024.