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Program Engineer Salary in Connecticut, USA

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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.
Principle Engineer
Insight Global, Danbury
This position is responsible for leading the design, development, programming and implementation of new systems and controls for future pharmaceutical manufacturing processes and plant automation systems for full compliance with FDA regulations, reporting directly to the site lead for systems and controls. Support the facility, utility, manufacturing and packaging related control systems. Train, Design, and Troubleshoot controls and instrumentation systems to resolve discrepancies. Lead current and future equipment purchases, while vetting preferred vendors and insourcing contracted labor. Leads through hands on methodology to programming, installation, and configuration of systems. Create design of experiments for testing and execute test strategies, prepare and execute protocols, analyze results using statistical methods, prepare technical reports and write standard operating procedures. Manage project schedules through integrated product teams to coordinate control related activities, validation, Process Engineering, Facilities Engineering, Manufacturing, and/or Quality. Support and perform calibrations. This position is hands-on management leading by doing, training, and supporting teams throughout the organization.Responsibilities:Direct experience with Allen-Bradley Programmable Logic Controllers (PLC) programming, FactoryTalk SE/ME (HMI), Servo drives, ELAU, B&R PLC programming, Zenon SCADA and supporting software is required.Solid understanding of computers, networking and communication protocols used with industrial controllers, along with the ability to troubleshoot equipment problems and perform complex system tests.Knowledge of Rockwell Automation RsLogix5000, Siemens S7 TIA portal, ELAU PLC software, Wonderware InTouch, and Wonderware Industrial Application Server is highly desired.Experience with motion control, Cognex and Keyence vision systems, fieldbus communications (Ethernet/IP, Profibus, DeviceNet, ControlNet etc.), robotics, Kepware software and Safety PLCs is desired.Design, specification, programming, simulation and testing of control systems, utilities systems, and building automation within existing and new facilities for full compliance with FDA regulations.Create proactive plans to ensure all plant Automation, Process, and Robotic Systems have minimized downtime. Analyze, troubleshoot, and create electrical circuitry using schematics and autodesk.Leads and Supports facility, utility, manufacturing and filling/packaging related control systems along with capital projects. Execute with minimal guidance from Director of Systems and Controls Engineer, and lead department control system projects, schedules, and other necessary control system project tasks.Supports facility, utility, future manufacturing and filling/packaging related control systems along with capital projects.Review documentation, methods, equipment, and procedures to improve efficiencies.Domestic and overseas travel to equipment vendor facilities for FAT execution and other project assignments (Utilize life cycle methodologies and standards (GAMP5, S88, S95, 21 CFR Part 11) for the design, development, installation, qualification, and validation of existing and future control systems and building management control systems.Evaluate and select upgrades for legacy equipment to ensure proper part obsolescence initiatives are met.Other duties include, but not limited to, troubleshooting control and instrumentation systems to resolve discrepancies, install automated systems, configure automated systems, develop test strategies, execute test strategies, prepare protocols, execute protocols, prepare technical reports and write standard operating procedures.Develop control systems documentation, SOPs, along with system change controls, IQ, OQ, FAT/SAT/Commissioning, as required, to provide ongoing upgrades and new systems in support for cGMP Manufacturing and Utility control systems.Update and/or produce electrical drawings, control panel layouts, and other technical documentation in support of new or existing control systems.Work cross functionally with Validation, Facilities, Calibration, Manufacturing, Process, and Engineering efforts and other cross functional departments requiring controls related assistance and SME (Subject Matter Expert) expertise.Maintains and optimizes the Computerized Maintenance Management System (CMMS).Periodically review automation documents, preventive maintenance, and standard operating procedures to ensure compliance with GMP, environmental, and safety regulations.Develop corrective actions for automation anomalies and oversee investigations to prevent recurrence.Responsible for observing all Company, Health, Safety and Environmental guidelines.Execute with minimal guidance from Director of Systems and Controls Engineer, and lead department control system projects, schedules, and other necessary control system project tasks.Supports facility, utility, future manufacturing and filling/packaging related control systems along with capital projects.Review documentation, methods, equipment, and procedures to improve efficiencies.Domestic and overseas travel to equipment vendor facilities for FAT execution and other project assignments (Utilize life cycle methodologies and standards (GAMP5, S88, S95, 21 CFR Part 11) for the design, development, installation, qualification, and validation of existing and future control systems and building management control systems.Evaluate and select upgrades for legacy equipment to ensure proper part obsolescence initiatives are met.Other duties include, but not limited to, troubleshooting control and instrumentation systems to resolve discrepancies, install automated systems, configure automated systems, develop test strategies, execute test strategies, prepare protocols, execute protocols, prepare technical reports and write standard operating procedures.Develop control systems documentation, SOPs, along with system change controls, IQ, OQ, FAT/SAT/Commissioning, as required, to provide ongoing upgrades and new systems in support for cGMP Manufacturing and Utility control systems.Update and/or produce electrical drawings, control panel layouts, and other technical documentation in support of new or existing control systems.Required Skills & Experience:BS or Technical degree in engineering controls or a related field with 10-15 years of experience or MS/MBA with 7-10 years of experience or the equivalent combination of training and experience.In-depth knowledge of PLCs, SCADA, HMIs, Vision system, Robotics and Visual Basic.Proven ability to program PLCs, HMIs. Effective project management skills. PMP preferred.Subject matter expert knowledge of Allen Bradley and Siemens controllers. Graphical layout and design ability for HMI's a plus.Mastery knowledge of networks used in Manufacturing such as EtherNet, DeviceNet, Foundation Fieldbus, and others.5+ years experience operating, qualifying or developing batch processes, pure water systems, compressed air systems, HVAC systems, and Filling Units. (Lyophilizers, Freezers and Refrigerators a plus)Understanding and knowledge of ISA S88 and S95.Subject Matter Expert of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations and industry trends.Sr. Level experience working in a regulated industry (Medical/Aerospace/Automotive), Knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirement a plus.Mastery level in technical writing, verbal communication, interpersonal and problem-solving skills is required.Proven ability to work independently, lead a team of peers and manage assignments cross-functionally. Mastery level knowledge of historian data storage such as Wonderware InSQL, Factorytalk Historian, and query programs for real-time control systems a plus.Onsite work required, limited ability to be virtual/remote. Must be able to be "get dirty" and work hand and hand with mechanics, production engineers and interns. Position is not desk bound. Mastery level knowledge of Microsoft Word®, Excel®, Visio®, PowerPoint®, and AutoCAD®. Solidworks and G-code experience a plus.
Engineer IV, Injectables Drug Product Development
AstraZeneca, New Haven
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.
Project Engineer
Zobility, Windsor Locks
seeking a Project Engineer with a strong technical background to lead Engineering Integrated Project Teams (IPTs) in the Deep Space Portfolio in Space Systems. This position will take direction from the Engineering Leads in Lunar/Mars Transport Platforms, Lunar/Mars Orbital Platforms, or Lunar/Mars Surface Platforms. Deep Space hardware includes components for Active Thermal Control Systems (ATCS) and Environmental Control and Life Support Systems (ECLSS) for the Orion Spacecraft and for Gateway Lunar Space Station modules including the Habitation and Logistics Outpost (HALO). Pursuits include ATCS and ECLSS components for the Exploration Command Module (Mars Transit Vehicle), Gateway Airlock, Gateway International Habitat (I-HAB), Lunar Landers, and Pressurized Rover as well as Surface Power and Fuel Cells for Lunar Infrastructure.Responsibilities• Drive world class project management process using integrated scheduling, earned value management, and risk and opportunity management• Work collaboratively with other Engineering disciplines (Systems, Software, Mechanical, and Electrical), Programs, Production, Quality and Supply Chain to develop an integrated execution plan to satisfy customer requirements across applicable operating conditions• Facilitate project tasks with the various functional organizations to ensure alignment with overall project objectives.• Track team's integrated execution performance to plan• Analyze, identify, and address execution problems, recommend and implement resolutions to ensure the successful completion of project(s)• Forecast project revenues, monitor costs, and re-estimate project costs monthly to maximize project profitability and ensure business objectives are met• Maintain and present plans and progress reports relating to business aspects of the project(s) to track progress and ensure that established targets are met.• Ability to balance demands of multiple projects• Work autonomously with limited oversight from manager• Support root cause investigations and corrective actions for field returns and production issues• Develop bids based on customer proposal requests• Participate in continuous improvement efforts for project execution efficiency• Champion superior ethical and professional behavior in all situationsThe candidate will drive the execution of all engineering responsibilities on the program while meeting both internal and external customer expectations. Direct communication with customers will be required. This position requires strong interpersonal and communication skills (both verbal and written), technical experience, and the ability to work as cross-functional team member.