Engineer I (Lab Testing & Operations)
Amgen
3 hours ago
On-site
Cambridge, MA
Operations
Engineer I (Lab Testing & Operations)
What You Will Do
- Plan and execute hands-on device and final product characterization testing for biological drug delivery systems and combination products.
- Operate as technical resource for equipment (e.g., viscometers, densitometers, UV-Vis spectrometers, 3D printers, environmental chambers, tensile testers, manual presses, balances).
- Author, review, and execute test protocols, workbooks, test methods, reports, and technical documentation per GDP/GLP.
- Record experiment design, methods, sample traceability, results, and observations in electronic lab notebooks.
- Perform statistical/engineering data analysis; summarize findings and provide technical recommendations.
- Support cross-functional programs via lab testing, data verification, sample management, and coordination.
- Maintain lab readiness (equipment coordination, preventive maintenance support, calibration readiness, workspace organization).
- Lead safety oversight and participate in lab safety assessments.
- Lead/support continuous improvement (workflow optimization, 5S, safety and storage/process improvements).
- Train staff on procedures, equipment use, documentation, and safe/compliant practices.
- Support problem-solving/root-cause analysis and implement improved methods.
- Partner cross-functionally to align test execution with project needs/timelines.
- Support digital transformation workflows (data organization, traceability, dashboards).
- Ensure documentation and reporting are inspection ready.
What We Expect of You
Basic Qualifications:
- Master’s degree OR Bachelor’s + 2 years engineer experience OR Associate’s + 6 years OR HS/GED + 8 years.
Preferred Qualifications:
- 5+ years hands-on lab testing/support; technical documentation experience; strong comms; detail/organization/multi-priority skills; training & continuous improvement; independent + team collaboration.
- Pharma/medical device/combination product environment experience; GDP/GLP/safety knowledge.
- Equipment experience (e.g., viscometers, densitometers, UV-Vis, tensile testers, environmental chambers, 3D printers).
- Data visualization/dashboarding (Tableau/Power BI/Spotfire/JMP or similar); ELNs (e.g., Dassault 3DS Biovia); stats/data analysis (JMP/Minitab); CAD (e.g., SolidWorks).
Benefits (if part of job posting)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications continue until sufficient candidates or a selection is made. Sponsorship not guaranteed.
What You Will Do
- Plan and execute hands-on device and final product characterization testing for biological drug delivery systems and combination products.
- Operate as technical resource for equipment (e.g., viscometers, densitometers, UV-Vis spectrometers, 3D printers, environmental chambers, tensile testers, manual presses, balances).
- Author, review, and execute test protocols, workbooks, test methods, reports, and technical documentation per GDP/GLP.
- Record experiment design, methods, sample traceability, results, and observations in electronic lab notebooks.
- Perform statistical/engineering data analysis; summarize findings and provide technical recommendations.
- Support cross-functional programs via lab testing, data verification, sample management, and coordination.
- Maintain lab readiness (equipment coordination, preventive maintenance support, calibration readiness, workspace organization).
- Lead safety oversight and participate in lab safety assessments.
- Lead/support continuous improvement (workflow optimization, 5S, safety and storage/process improvements).
- Train staff on procedures, equipment use, documentation, and safe/compliant practices.
- Support problem-solving/root-cause analysis and implement improved methods.
- Partner cross-functionally to align test execution with project needs/timelines.
- Support digital transformation workflows (data organization, traceability, dashboards).
- Ensure documentation and reporting are inspection ready.
What We Expect of You
Basic Qualifications:
- Master’s degree OR Bachelor’s + 2 years engineer experience OR Associate’s + 6 years OR HS/GED + 8 years.
Preferred Qualifications:
- 5+ years hands-on lab testing/support; technical documentation experience; strong comms; detail/organization/multi-priority skills; training & continuous improvement; independent + team collaboration.
- Pharma/medical device/combination product environment experience; GDP/GLP/safety knowledge.
- Equipment experience (e.g., viscometers, densitometers, UV-Vis, tensile testers, environmental chambers, 3D printers).
- Data visualization/dashboarding (Tableau/Power BI/Spotfire/JMP or similar); ELNs (e.g., Dassault 3DS Biovia); stats/data analysis (JMP/Minitab); CAD (e.g., SolidWorks).
Benefits (if part of job posting)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications continue until sufficient candidates or a selection is made. Sponsorship not guaranteed.