Validation Engineer Salary in Boston, MA

SummaryA Process Engineer is responsible for ensuring the operability and reliability of GMP manufacturing process equipment located at manufacturing facilities. This Candidate provides process engineering service support and coordinates various engineering activities with outside groups (e.g., Manufacturing, Facilities, Validation, Quality). This individual will also work closely with Equipment SMEs, MS&T, and equipment End Users to investigate and troubleshoot issues related to process equipment.ResponsibilitiesInstallation and startup testing of new equipment (generation, execution, and close out of engineering test plans)Ownership of system P&IDs - responsible for engineering review, walk-downs, redlines & system changes.Generation, review, and approval of engineering lifecycle documentation for assigned systems.Review, approval, and execution support of C&Q protocols for assigned systems.Generation, review, and approval of engineering change management for assigned systems.New systems troubleshooting floor support.This individual will work closely with Equipment SMEs, MS&T, and equipment End Users to investigate and troubleshoot issues related to process equipment.Provide direct engineering support and Subject Matter Expertise for process equipment such as: (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc...). This includes serving as the Engineering owner for process equipment.Skills required to meet expectations of the role include high-quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.Provide daily, on-the-floor support to manufacturing.Facilitate tech transfer, process fit, and facility fit for new projects.Support the team goal of achieving gold standard batches and right the first-time processing.Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required.Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.Other duties as assignedSkills and Qualifications4-6 Years experience in a GMP manufacturing/engineering environment and a B.E. / B.S. degree in Chemical Engineering.Must have experience in installing and executing new equipment.Must have previous Biotech or Biopharmaceutical industry experience working in a process engineering roleMust have strong knowledge and experience supporting cleaning (CIP, COP, glass washers, detergent distribution), sterilization (SIP, autoclaves), bench?top analytics (Cedex, Nova, filter integrity testers) and single?use systems.Good report and technical writing skills with the ability to drive changes in a cross-functional team environmentExperience with all aspects of biotech and pharmaceutical industries.Demonstrates good interpersonal skills, is attentive and approachable.Maintains a professional and productive relationship with area management and co-workers.Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.Additional Skills Required:In order to perform a client assignment for DPS successfully, an individual must be able to perform each essential duty to a high technical standard. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.• Continuous Learning -Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.• Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.• Customer Services - Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.• Planning and Organizing - Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.• Teamwork - Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Puts success of team above own interests.• Use of Technology - Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.• Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.• Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.• Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.The CompanyDPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.

Consultant EngineerUS--Job ID: 2024-6726Type: Regular Full-Time# of Openings: 1Category: OPERATIONSRemote - United StatesOverviewNWN Carousel is the leading Cloud Communications Service Provider (CCSP) focused on transforming the customer and workspace experience for commercial, enterprise, and public sector organizations. We deliver hybrid work experiences for millions of users across North America’s 7,000 leading organizations. Our integrated devices, communications apps, AI-enabled contact centers, networking, security, and analytics allow our customers to learn, discover, work, and connect from anywhere - all delivered as a cloud service that’s simple to use and manage. To learn more about our solutions please visit www.nwncarousel.comResponsibilitiesRole OverviewThe Consultant Engineer role is responsible for the configuring, installing, troubleshooting and repairing offerings technical solutions for our customers.Scope of Role ResponsibilitiesEssential, key job responsibilities for this role include, but are not limited to:Configuring, installing, troubleshooting and repairing offerings technical solutions for our customers.Meeting the billable/chargeable targets set by the company. Billable and chargeable time should consist of assessments, planning, design, configuration, installation and support of the solutions offered by the practice.Assisting Presales and Marketing where applicable. Specifically supporting the team with validation of solution designs, bill of materials, statements of work, and labor estimate when appropriate.Attending seminars as requested by the Professional Services Management Team.Consistent, accurate and timely tracking of client work, service calls, and related documentation including timesheets.Travel: To Customer sites as needed. Access to a vehicle is required.Additional job responsibilities include, but are not limited to:Assisting the team with the creation of technical tools and templates to help improve the quality of the service delivery process.Developing partner SE/Peer relationships.Supporting internal technical projects where applicable.Acquire technical certifications per training plan.Attend technical classes and web training.Other responsibilities as assigned.3 to7 years of:Palo Alto delivery\troubleshooting experience.Aruba Wireless, ClearPass and Switch experience.Cisco Enterprise and Security experience.QualificationsRole Qualifications and RequirementsThe following are minimum qualifications and requirements required for this role:At least 7 years of experience that is directly related to the duties and responsibilities specifiedAbility to relay technical information to both technical and non-technical personnelStrong written/verbal communication skills, critical thinking and problem solving or troubleshooting skillsMust possess excellent time management skills.Ability to travel to client premises daily if required.Ability to work evenings and weekends as required during client cutovers.This position requires a high level of independence and strong client service skills. Organizational ability is important to keep track of all tasks because the job requires a great deal of multi-tasking.Must be a team player yet work well independently.Excellent verbal and written communication skills.Must have reliable transportation.Must supply reliable cell phone. Cell phone costs may be reimbursed.The following qualifications are ideal, but not required:Bachelor’s degree preferred.At least one major vendor certification (Palo Alto PCNSE, Aruba ACSP or ACEP, CCDA, CCNP, CCIE, CCNA, VCP, Microsoft MCSE, MCITP, Citrix CCEA, etc.).NWN Carousel is an Equal Opportunity Employer: NWN Carousel provides equal employment opportunity to all employees and applicants for employment free from unlawful discrimination based on race, color, religion, gender, age, national origin, disability, veteran status, marital status, sexual orientation or any other status or condition protected by local, state or federal law.Equal Opportunity Employer, including disability/protected veteransPI239475096

Careers that Change Lives In this role, y ou will join a world class team of mechanical, electrical and software engineers responsible for further development and enhancement of the globally launched Robotic Assisted Surgery platform within the Surgical Operating unit: https://www.medtronic.com/covidien/en-us/robotic-assisted-surgery/hugo-ras-system.htmlMedtronic's Surgical Operating Unit is one new, powerful operating unit bringing together the people and product portfolio of Surgical Robotics and Surgical Innovations. With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of the customers and patients we serve.Make your impact by exploring a career with the world's leading Medical Device company, striving "to alleviate pain, restore health, and extend life." A Day in The Life Located at the Medtronic office in the Seaport District of Boston, MA, or North Haven, CT, as a Platform Software Engineer you will lead and/or participate in the software development efforts in the Software Center of Excellence of the Surgical Operations Organization. You will work in a fast-paced environment with a group of software engineers, collaborating with cross functional teams to complete requirements definition, design, code implementation, unit test, and software and system verification and validation.Engineers create our market-leading portfolio of innovations. Combine the best of your experience with training and mentorship to move your career forward. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide. Must Have: Minimum Requirements Bachelor's degree and a minimum of 4 years of relevant experience, or advanced degree and minimum of 2 years of relevant experience. Nice to Have Bachelor's degree or advanced degree ideally in Computer Engineering, Electrical Engineering, or Computer Science.As an ideal candidate, you would have some of the following experience:Understanding of Windows, Linux, QNX or other operating system operation, drivers, interfaces, and coding in these environments. Including but not limited to applications, processes, threads, handles, synchronization, drivers, virtual memory, kernel objects, performance counters, key performance indicators, performance analysis, networking, root causing, troubleshooting, and debugging in a complex multi-processor mixed OS environment.Experience in developing and commercializing software products in a fast-paced R&D environment, including understanding of the software development lifecycle (SDLC) and best practices in the medical device industry, experience in providing post product support.• Experience in hands-on development and troubleshooting on targets using modern C++ 11 or greater.• Experience in object-oriented design and design patterns.• Experience in relevant scripting languages (e.g. PowerShell, Python, Bash)• Understanding and appreciation of SDLC process and tools (e.g. JIRA, Bitbucket, Stash, Confluence, JAMA, Git, CMake.)• Experience in software development in medical device industry or other regulated industry is preferred.• Experience in the test-driven development methodology and unit test.• Experience in Agile/Scrum/SAFe software development practices.• Ability to distill software requirements from system requirements.• Experience with Windows OS, QNX (x86 and/or Arm target), Linux and/or other Real Time Operating System, including related IDEs, SDKs, and DDKs.• Experience with Transport layer communications protocols and related network experience (e.g. DDS TCP/IP, UDP, Sockets, Wireshark, etc.)• Experience Troubleshooting, Debugging, and Root Cause Analysis techniques and tools (e.g. WinDbg, GnuDbg, others)• Experience performing risk management analysis of software ideally using SW FMEA techniques• Experience working with the global/multi-development sites environment is a plus.• Cybersecurity experience is desirable, designing and maintaining secure OS and applications (e.g. SSL/TLS, DTLS, TPM, Trusted/Secure Boot, Root of Trust, Authentication, Encryption, Public/Private Key, Key/Certificate Management, authenticated and secure communications protocols) About Medtronic Together, 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. Benefits & Compensation 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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). Learn more about MIP and benefits here .The provided base salary range is used nationally (except in 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 Requirements The 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.

Equal Employment Opportunity/M/F/disability/protected veteran statusAzzur GroupAzzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!Responsibilities: Lead and oversee the commissioning, qualification, and validation activities related to pharmaceutical manufacturing and facility systems, including process equipment, utilities, HVAC, cleanrooms, and automation systems. Develop and execute validation protocols (IQ, OQ, PQ) and associated documentation, ensuring compliance with regulatory requirements and industry standards. Conduct risk assessments and impact assessments to determine the criticality of systems and equipment, identifying areas that require validation and ensuring appropriate validation strategies are implemented. Provide technical expertise and guidance to cross-functional teams on validation requirements, best practices, and compliance issues. Collaborate with internal stakeholders, including Quality Assurance, Engineering, Manufacturing, and Regulatory Affairs, to ensure alignment and adherence to validation procedures and timelines. Perform qualification activities, including equipment installation, operational testing, performance testing, and cleaning validation. Analyze validation data, generate validation reports, and document any deviations or non-conformances, implementing corrective and preventive actions as needed. Stay up-to-date with current regulations, industry trends, and technological advancements related to validation practices, ensuring compliance and suggesting process improvements when appropriate. Participate in regulatory inspections and audits, providing support and documentation as required. Mentor and provide guidance to junior validation engineers, promoting professional development and knowledge sharing within the team.Qualifications and Experience: Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field. Minimum of 8-10 years of experience in commissioning, qualification, and validation activities within the pharmaceutical or biotech industry. In-depth knowledge of regulatory guidelines and requirements, including FDA, EMA, and ICH guidelines. Strong understanding of validation methodologies, such as risk-based validation, process validation, cleaning validation, and computer systems validation. Experience in authoring and executing validation protocols (IQ, OQ, PQ) and generating associated documentation. Proficient in utilizing validation tools, software, and statistical analysis methods. Excellent problem-solving skills and attention to detail, with the ability to analyze complex data sets and identify trends or deviations. Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and present validation findings to stakeholders. Experience working in a GMP-regulated environment, with knowledge of cGMP principles and industry best practices. Professional certifications such as Certified Validation Professional (CVP) or Certified Quality Engineer (CQE) are desirable. Experience with custom equipment validation a huge plus.Do What You LoveAt Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.PI239287916

Facilities Site Engineer (Biotech)Location - BostonADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.This is an outstanding opportunity to join our growing team!KEY RESPONSIBILITIES: Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned. Manage creation, revision and review of Protocols, Reports, and Engineering Documents including, but not limited to, IOV, drawings, user requirement specifications and SOP's. Effectively work with cross departmental stakeholders to achieve departmental goals and objectives Supply GEP (Good Engineering Practice) expertise drawn from own experience and/or supplemented by external resources to trouble shoot facility, equipment or system issues. Balance degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate. Must exhibit mechanical abilities including tool familiarity, lifting, climbing a ladder and gown into cleanrooms IDEAL CANDIDATES: Demonstrate planning and organizational skills, including complex project management. Ability to lead by influence. Foster change and innovation - Seeks solutions that strengthen quality, value, service and effectiveness Demonstrate business acumen and business agility - Demonstrates functional/technical proficiency, engages in effective operational and strategic planning Accountable for Results - Translates goals/objectives into actionable plans and results Able to work on multiple projects and manage various priorities and timelines Demonstrates proficiency in the following competencies: Responsive to change - Adapts (quickly) to changing circumstances Model collaboration and commitment - Focuses on team success before individual success. Demonstrates operational excellence - Continually looks for new and better ways to get things done and shows functional/technical proficiency in work.Demonstrates effective self-management - Seeks to understand and act upon improvement opportunities. Ability to review Engineering Document and Models (CAD, Revit etc.) Ability to use Project Management tools PREFERRED QUALIFICATIONS B.A, B.S. in Engineering or related discipline with at least 5 years of relevant experience or M.S. in related field. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. Knowledge of facility related engineering disciplines (MEP) in GMP manufacturing environment Excellent verbal and written communication skills applied on a global or multi-national basis. Strong interpersonal skills, including the demonstrated ability to manage through influence

DESCRIPTIONAmazon created one of the most sophisticated supply chains in the world. From the introduction of Amazon Prime, to the use of advanced technology for package delivery; Amazon consistently drives change from the front of the pack. As an Amazon Logistics [AMZL] Operations Engineer, you will lead and manage the lifecycle of challenging cross-functional projects, developing and delivering the next generation of sortation and distribution solutions. You are a customer obsessed leader that will play an integral part in planning and implementation of the facility network infrastructure including new builds, retrofits, expansions and program initiatives. Partnering with internal customers and internal/external stakeholders to engage as a team and ensure a timely handover will be part of your critical tasks. Key competencies of this position include insisting on the highest standards ensuring that contracted resources meet schedule, budgetary, safety and driving quality targets; analyzing and deep diving systems performance, inventing and simplifying solutions that allow for improved processes and results; and providing technical expertise to internal customers and stakeholders.Key job responsibilities• Work independently with internal and external teams to successfully manage the lifecycle of the challenging projects, and act as owner in delivering on projects objectives and targets. Projects may span organizations or geographies in support of business objectives. • Actively participate in firm engineering reviews, and make tangible impact on the proposed solutions on an individual system or its components, on the overall systems architecture, and on facility processes . • Partner with internal teams, stakeholders and external vendors to set project priorities, establish milestones, and drive schedules to meet deadlines. Proactively assess stakeholders’ dependencies and milestones, problem-solve and drive solutions to mitigate the impact from the issues.• Lead and coordinate all execution efforts in delivering systems and automated equipment designs per established standards and guidelines. Perform equipment/systems installation, throughput and safety qualifications. Simplify, optimize, remove bottlenecks and provide feedback while resolving difficult system problems or technical deficiencies. • Lead effective meetings by setting the objectives, putting the right people in the room and driving detailed business and technical discussions/alignment. Document meetings discussions, decisions and future steps ensuring alignment on expectations with internal partner teams and outside vendors.• Promptly and accurately communicate project status, risk analysis and risk mitigation plans. Effectively answer project questions in detail, and regularly produce clear and concise summaries for the projects to leadership/management team. • Competently articulate system and/or equipment designs, including layouts, technical specifications and functional capabilities, to internal customers and partner teams. • Efficiently manage change order controls, purchase orders, and invoice validation/approvals. • Excel at building strong working relationships with internal and external stakeholders across multiple projects• Identify and lead process improvement initiatives that improve the Engineering and cross-teams’ efficiencies, optimizing the teams’ value and delivery. Through collaboration, generate high-quality, cost-effective solutions in compressed periods of time. • Travel up to 80% domestically although travel intensity can be variable and consist of up to three weeks in a row, including weekends.A day in the lifeYou are managing quality of implementation through multiple projects that can vary in scope, complexity and duration. Daily tasks may comprise of site coordination with operations teams and contractors on project execution activities or changes; deep diving project progress, schedule and resources, while identifying barriers, creating solutions and driving resolutions. You may be facilitating the planning and/or implementation meetings with projects’ stakeholders, ensuring alignment in objectives, expectations, and the next steps; you would capture and publish detailed notes after each meeting to drive ownership and follow-through on the actions and decisions. Reviewing/approving audit mechanisms and documentation is one of the essential tasks, and you may be tracking the programmatic week on week installation opportunities with the internal automation teams. You may be brainstorming and developing workaround solutions while mitigating the project delays or design issues. As a part of the acceptance testing you may be performing systems installation quality, safety, throughput and performance qualifications, frequently communicating the progress to internal and external stakeholders. In addition, you may be supporting/training other engineering team members, utilizing the knowledge of Amazon’s safety, mechanical, electrical and controls installation standard and guidelines. About the teamAt Amazon, we are all Owners and leverage unique opportunities presented to us by owning everythingfrom firm engineering to project execution and final hand-off to our customers. We are a diverse,upbeat, creative team of engineers and managers working on a daily basis to ensure that our internalcustomers have capabilities to deliver on the Customer Promise.We not only build, but we are also consistently improving our capabilities at Amazon. Continuousimprovement is the ongoing enhancement of our systems designs, through incremental andbreakthrough developments. We are continually raising the quality bar, and are never satisfied.We seek to improve through captured lessons learned, that are incorporated back into our mechanismsas a way to perpetually improve upon the next design and processes iterations. We continually learn, grow and develop throughout the organization and our Subject Matter Expertise isleveraged globally.We are the Team! We collaborate, support, help and leverage each other in delivering on the businessobjectives. We are open to hiring candidates to work out of one of the following locations:Boston, MA, USA | Bronx, NY, USA | Hartford, CT, USA | Manchester, NH, USA | North Reading, MA, USA | Quincy, MA, USA | Taunton, MA, USABASIC QUALIFICATIONS- Bachelor’s Degree in Industrial Engineering, Electrical Engineering, Mechanical Engineering, or other STEM field.- 3+ years of experience as a project engineer, process engineer, project manager, manufacturing engineer, or related occupation.- Experience with leading projects, programs or initiatives with continually increasing scope and impact.- Experience managing the lifecycle of cross-functional projects, implementing automated equipment and/or integrated systems.- Experience with CAD software (AutoCAD, REVIT, BIM 360, etc.).PREFERRED QUALIFICATIONS- Master’s degree in Engineering, Operations, Business Administration, or a related STEM field.- Operations Management/Distribution Center experience with direct management or responsibility for material handling, automation, or other technical projects.- Experience with Six Sigma and/or Lean Manufacturing.- Experience with Microsoft Project, Smartsheet programs.- Experience with design and/or implementation automation solutions, such as Conveyors, Sorters, high speed manufacturing and packaging lines, Robotic work cells.- Proven technical leadership for industrial engineering projects or programs.Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $61,300/year in our lowest geographic market up to $126,400/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. Applicants should apply via our internal or external career site.

ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems, and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team!Requirements:Support lifecycle engineering of Upstream Bioprocessing hardware products, components, and assemblies through design, testingAnalyze and validate designs per user requirements to meet performance, cost, compliance, and manufacturability targets.Author design verification and validation documentation, and develop test methods, test procedures and work instructions.Modify electrical schematics.Support customer complaint investigations by troubleshooting, conducting product testing, Root Cause Analysis.Perform product risk assessment and product quality investigations.Closely monitor and track project schedules against agreed milestones, including supporting identification and management of relevant critical paths and dependencies.Proactively identify project issues and risks, support issue resolution, and develop risk mitigation plans in close partnership with project teams and relevant business partners.Proactively build relationships across various functions and levels across the organization to ensure effective stakeholder management. Lead project team meetings, including agenda development, meeting facilitation, and documentation of meeting minutes.Create and present project updates to communicate status, issues and risks.Qualifications:Requires a bachelor's or master's degree in mechanical engineering, Electrical Engineering, or related discipline. Looking for 3 plus years of experience in the biotech-pharmaceutical academic or industrial environment.Experience with Commissioning and Qualification.Electrical CAD drafting skillsStrong technical writing with proficiency in Excel, PowerPoint, Visio, Word, SharePoint, etc. in addition to experience working within shared work environments.Travel within USA as needed for the projects.

SummaryDPS Group is seeking a Senior Process Engineer that can design, implement and optimize biochemical and chemical systems. Responsible for ensuring the operability and reliability of GMP manufacturing process equipment. Successful candidates need to be able to work closely with Facilities, MS&T, and equipment end users to investigate and troubleshoot issues related to process equipment. Must be able to enjoy working in a fast-paced dynamic and innovative environment.ResponsibilitiesServe as a Technical Lead for Capital projects, overseeing GMP manufacturing process equipmentCollaborate closely with MS&T, Facilities, Validation, and equipment End Users to successfully drive projects to completionEnsure that projects are executed efficiently and effectively to meet objectives and timelinesProvide direct engineering support and Subject Matter Expertise for process equipment such as the following: (Ultrafiltration, Chromatography, Mixing Systems, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.)Drive results by owning and completing medium to large-sized projects with challenging timelines and complex subject matterProvide high-quality technical writing within the required quality systems and meet project timelines to ensure the production schedule is not impactedParticipate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipmentTroubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated Change ControlsOwn quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as requiredProvide input into preventative maintenance plans, assessing Change Controls, and continuous improvement initiativesMaintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment• Other duties as assignedSkills and QualificationsA bachelor's degree in Chemical or Mechanical EngineeringMinimum of 7 years relevant experience as a Process EngineerExcellent interpersonal and communication skills (verbal and written) are requiredExpected to be able to present own work to peers and cross-functional managers and influence leadership decisionsTechnical writing skills requiredMust be able use his/her technical background to investigate issues using a structured problem-solving approach to determine root cause and develop effective corrective and preventative actionsMust be able to be able to find root cause and path forward for complex problemsAbility to interact well with other groups and must be able to take ownership of and follow through on assignmentsMust be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor• Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.Additional Skills Required:In order to perform a client assignment for DPS successfully, an individual must be able to perform each essential duty to high technical standard. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Continuous Learning -Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills. Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship. Customer Services - Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service. Planning and Organizing - Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner. Teamwork - Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Puts success of team above own interests. Use of Technology - Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity. Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees. Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations. Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations. The CompanyDPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up. DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.

Hybrid - 3 days on site weekly - Irving, TX Data Engineer : Implementation Consultant Summary We are currently onboarding North America based OPCO' s (Operating companies) to their new digital platform (Spark) which is built on Kubernetes running in AZURE, the customer and associate experience (CX/AX) on their new SPARK platform in EMEA. They are planning to migrate North American operating companies (OPCOs) to the platform, beginning in 2024. With this integration work the engineer will be responsible for designing, configuring, and implementing data validation tools which will validate the data transferred between. You will ensure best practices are followed through the implementation lifecycle and help construct data sets for use by the team and other business stakeholders to power both reporting and validation. Job responsibilities Highly skilled and motivated Data Engineer As a Data Engineer, you will be responsible for validating the data between two systems, ensuring accuracy and consistency. Implement data quality checks and monitoring processes. Design and Develop data entity validation scripts using python. Validate and reconcile data between two systems, ensuring accuracy and consistency. Collaborate with cross-functional teams to identify and resolve data discrepancies and issues. Develop and implement data quality checks and monitoring processes to ensure data integrity. Design and maintain data pipelines and ETL processes to extract, transform, and load data from various sources. Optimize data storage and retrieval processes to improve performance and efficiency. Perform data analysis and profiling to identify data quality issues and recommend solutions. Develop and maintain documentation for data validation processes, data mappings, and data lineage. Stay up to date with industry trends and best practices in data engineering and data validation. Support migration of North American OPCOs, enabling data validation on the new platform. Gather business requirements from key client stakeholders and translate these into technical tracking specifications based on standards and industry best practice. Required Skills Strong knowledge of IPAAS and data validation for migration of applications. Demonstrable experience in delivering end to end data validation. Confident understanding of web development and its languages and possess Python proficiency. Proactive and highly organised with strong time management and planning skills. Able to change direction and work on multiple projects across a wide range of topics. [Desired] Knowledge of Python/Google BigQuery architecture.

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.Title: Veeva EngineerLocation: Boston, MA (3 days a week in office)Implement IT Management / IT Business Partners plans and processes to drive priorities and deliver systems/ applications development, hardware acquisition and integration requirements in line with Galderma's guidelines and policies• Deploy system process analysis tools and methods, analyze and document business processes and metrics, and identify improvement opportunities to streamline processes• Contribute to future-oriented plans and recommendations for functional design initiatives and perform work across multiple areas of an organization's overall IT Platform/Infrastructure• Stay up-to-date with industry trends, vendor products, and services to stay ahead of competition and improve Galderma technology and best practicesKey Responsibilities:• Implementation and Configuration: The Administrator will be responsible for the configuration of Salesforce and Veeva Align, ensuring alignment with specific organizational requirements. This includes creating custom fields, workflows, validation rules, and user profiles.• Administration and Maintenance: The Administrator will be responsible for regularly maintaining and updating Salesforce and Veeva Align platforms. This involves user management, troubleshooting technical issues, optimizing performance, and applying updates and patches.• Support and Training: The Administrator will be the primary point of contact for Salesforce and Veeva Align US and Canada users within the organization. They will provide technical support and training to users, resolve issues, and respond to inquiries related to platform functionality and usage.• Continuous Improvement: The Administrator will work closely with internal teams to identify areas for improvement and opportunities to optimize business processes through Salesforce and Veeva Align configuration and customization. They will participate in planning and implementing new features and enhancements.Skills and Qualifications:• Bachelor's Degree in related field preferred• 3+ years of relevant experience administering Veeva or Salesforce CRM Required• Proven experience in Salesforce and Veeva Modules administration.• Technical skills for Salesforce and Veeva Align configuration, customization, and troubleshooting.• Experience in SQL• Experience in data loading• Ability to communicate well (English), excellent organizational and follow through skills with the ability to work prioritize• Strong analytical skills and capability to research and resolve discrepancies What we offer in returnYou will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.Next StepsIf your profile is a match, we will invite you for a first virtual conversation with the recruiter.The next step is a virtual conversation with the hiring managerThe final step is a panel conversation with the extended teamOur people make a differenceAt Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.Employer's Rights:This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.