Sr Engineer
Amgen
June 30, 2026
On-site
Thousand Oaks, CA
IT
Sr Engineer
What You Will Do
- Lead the creation of visual inspection defect standards to enable clinical and commercial new product introductions (NPIs) and support on-going manufacture of parenteral drug products at Amgen’s Thousand Oaks facility.
- Design, implement, and document on-site DP characterization studies, working instructions, SOPs, and protocols for visual inspection defect creations.
- Author and/or own high-quality technical and GMP documents.
- Ensure visual inspection process development adheres to required policies/procedures, including safety and training.
- Ensure site meets quality requirements and applicable regulations (FDA, EU, and global standards).
- Assist in development of existing visual inspection programs to maintain regulatory compliance.
- Build and sustain relationships with partners (drug product teams, NPI, QA, Process Development, and manufacturing) across the global network for alignment.
- Build, maintain, and improve visual inspection defect creations process; provide process development expertise.
- Demonstrate deep understanding of Amgen drug product and primary container platforms; support continuous improvement.
- Establish working relationships across the DP manufacturing network to share best practices and lessons learned.
- Act as single Point of Contact (POC) to the Amgen network as ATO defect creations leader.
- Location: Thousand Oaks, CA. Some US/international travel may be required.
What We Expect Of You
Basic Qualifications
- Doctorate OR Master’s + 2 years engineering/operations OR Bachelor’s + 4 years engineering/operations OR Associate’s + 8 years engineering/operations OR High school/GED + 10 years engineering/operations.
Preferred Qualifications
- Advanced degree in engineering/biotech/life sciences (4+ years drug product process development).
- Expertise leading visual inspection and defect creation deliverables; ability to set/achieve goals in dynamic manufacturing.
- Knowledge of aseptic processing and characterization (freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, visual inspection).
- Experience in cGMP and global regulatory requirements.
- Leadership of multi-functional teams; project management; matrix-collaboration experience.
- Ability to independently design/execute studies and author protocols/WIs/SOPs/technical reports.
- Technical problem-solving, critical thinking, initiative, communication, quality systems and GMP knowledge.
Benefits (Total Rewards Plan)
- Health/welfare benefits, retirement/savings plan, bonus/incentives, stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or selected.
What You Will Do
- Lead the creation of visual inspection defect standards to enable clinical and commercial new product introductions (NPIs) and support on-going manufacture of parenteral drug products at Amgen’s Thousand Oaks facility.
- Design, implement, and document on-site DP characterization studies, working instructions, SOPs, and protocols for visual inspection defect creations.
- Author and/or own high-quality technical and GMP documents.
- Ensure visual inspection process development adheres to required policies/procedures, including safety and training.
- Ensure site meets quality requirements and applicable regulations (FDA, EU, and global standards).
- Assist in development of existing visual inspection programs to maintain regulatory compliance.
- Build and sustain relationships with partners (drug product teams, NPI, QA, Process Development, and manufacturing) across the global network for alignment.
- Build, maintain, and improve visual inspection defect creations process; provide process development expertise.
- Demonstrate deep understanding of Amgen drug product and primary container platforms; support continuous improvement.
- Establish working relationships across the DP manufacturing network to share best practices and lessons learned.
- Act as single Point of Contact (POC) to the Amgen network as ATO defect creations leader.
- Location: Thousand Oaks, CA. Some US/international travel may be required.
What We Expect Of You
Basic Qualifications
- Doctorate OR Master’s + 2 years engineering/operations OR Bachelor’s + 4 years engineering/operations OR Associate’s + 8 years engineering/operations OR High school/GED + 10 years engineering/operations.
Preferred Qualifications
- Advanced degree in engineering/biotech/life sciences (4+ years drug product process development).
- Expertise leading visual inspection and defect creation deliverables; ability to set/achieve goals in dynamic manufacturing.
- Knowledge of aseptic processing and characterization (freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, visual inspection).
- Experience in cGMP and global regulatory requirements.
- Leadership of multi-functional teams; project management; matrix-collaboration experience.
- Ability to independently design/execute studies and author protocols/WIs/SOPs/technical reports.
- Technical problem-solving, critical thinking, initiative, communication, quality systems and GMP knowledge.
Benefits (Total Rewards Plan)
- Health/welfare benefits, retirement/savings plan, bonus/incentives, stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or selected.