Engineer
Amgen
5 months ago
On-site
Cambridge, MA
Other
Engineer
Responsibilities:
- Lead technology transfer and provide commercial support for biologics drug substance processes across the network (Amgen manufacturing and/or Contract Manufacturing Organizations).
- Implement manufacturing processes in a cGMP environment using engineering principles.
- Solve moderate-scope technical problems to enable technology transfer of clinical/commercial molecules.
- Evaluate and apply standard engineering techniques and procedures; seek guidance for unusual problems.
- Complete routine technology transfer tasks and troubleshoot manufacturing process performance issues.
- Monitor manufacturing processes for performance indicators; suggest problem resolution and provide troubleshooting mentorship.
- Use engineering principles and statistical analysis (including design of experiments) to address processing issues and identify process improvement opportunities.
- Partner with research, manufacturing, maintenance, process development, utilities, facilities, QA, and/or validation to develop requirements and recommendations for process/system modifications.
- Support design/engineering/construction projects within schedule and budget constraints.
- Collaborate with consultants/architects/engineering firms on standard design documents.
- Communicate and collaborate with technical and management staff across Manufacturing, Process Development, and Quality.
- Support non-standard shift organization and extended hours as needed; up to 15% travel (primarily domestic).
Basic Qualifications:
- Master’s degree OR
- Bachelor’s degree and 2 years of Engineering or Operations experience OR
- Associate’s degree and 6 years of Engineering or Operations experience OR
- High school diploma/GED and 8 years of Engineering or Operations experience
Preferred Qualifications:
- Master’s in Chemical or Biochemical Engineering; background in Chemical Engineering, Bioengineering, or Biotechnology.
- 2+ years in Process Development/Process Engineering, specifically downstream/purification support for commercial cGMP manufacturing.
- Experience with biologics process scale-up and technology transfer (lab → pilot and/or manufacturing scale).
- Experience manufacturing biologics with single-use technology.
- Basic understanding of cGMP requirements.
- Experience with downstream technology transfer/scale-up and ongoing cGMP biologics manufacturing, including nonconformance investigation support.
- Experience designing/optimizing downstream unit operations (harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, sterile filtration, etc.).
- Data analysis, troubleshooting, and problem-solving skills.
- Regulatory knowledge/interactions.
- Project management skills; strong oral/verbal communication and presentation skills.
Benefits (explicitly stated):
- Total Rewards Plan (eligibility-based): comprehensive benefits including Retirement & Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; award-winning time-off plans; flexible work models where possible.
Application instructions:
- Apply now via careers.amgen.com. No application deadline; applications accepted until a sufficient number of candidates are received or a candidate is selected.
Responsibilities:
- Lead technology transfer and provide commercial support for biologics drug substance processes across the network (Amgen manufacturing and/or Contract Manufacturing Organizations).
- Implement manufacturing processes in a cGMP environment using engineering principles.
- Solve moderate-scope technical problems to enable technology transfer of clinical/commercial molecules.
- Evaluate and apply standard engineering techniques and procedures; seek guidance for unusual problems.
- Complete routine technology transfer tasks and troubleshoot manufacturing process performance issues.
- Monitor manufacturing processes for performance indicators; suggest problem resolution and provide troubleshooting mentorship.
- Use engineering principles and statistical analysis (including design of experiments) to address processing issues and identify process improvement opportunities.
- Partner with research, manufacturing, maintenance, process development, utilities, facilities, QA, and/or validation to develop requirements and recommendations for process/system modifications.
- Support design/engineering/construction projects within schedule and budget constraints.
- Collaborate with consultants/architects/engineering firms on standard design documents.
- Communicate and collaborate with technical and management staff across Manufacturing, Process Development, and Quality.
- Support non-standard shift organization and extended hours as needed; up to 15% travel (primarily domestic).
Basic Qualifications:
- Master’s degree OR
- Bachelor’s degree and 2 years of Engineering or Operations experience OR
- Associate’s degree and 6 years of Engineering or Operations experience OR
- High school diploma/GED and 8 years of Engineering or Operations experience
Preferred Qualifications:
- Master’s in Chemical or Biochemical Engineering; background in Chemical Engineering, Bioengineering, or Biotechnology.
- 2+ years in Process Development/Process Engineering, specifically downstream/purification support for commercial cGMP manufacturing.
- Experience with biologics process scale-up and technology transfer (lab → pilot and/or manufacturing scale).
- Experience manufacturing biologics with single-use technology.
- Basic understanding of cGMP requirements.
- Experience with downstream technology transfer/scale-up and ongoing cGMP biologics manufacturing, including nonconformance investigation support.
- Experience designing/optimizing downstream unit operations (harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, sterile filtration, etc.).
- Data analysis, troubleshooting, and problem-solving skills.
- Regulatory knowledge/interactions.
- Project management skills; strong oral/verbal communication and presentation skills.
Benefits (explicitly stated):
- Total Rewards Plan (eligibility-based): comprehensive benefits including Retirement & Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; award-winning time-off plans; flexible work models where possible.
Application instructions:
- Apply now via careers.amgen.com. No application deadline; applications accepted until a sufficient number of candidates are received or a candidate is selected.