Engineer
Amgen
August 25, 2026
On-site
Thousand Oaks, CA
Other
Engineer – What You Will Do (Thousand Oaks, CA | Fully onsite)
Responsibilities:
- Provide manufacturing support for aseptic processing operations (technology transfer, process characterization, validation, deviation resolution, continuous process verification).
- Lead and implement on-floor characterization studies (fill recipe development for syringes and vials, process characterization, tech transfer studies, process validation, commercial manufacturing).
- Lead/assist process deviations, exception resolution, and root cause analysis; address issues with drug product processing technologies and equipment.
- Conduct risk assessments and propose/implement CAPA.
- Collaborate with manufacturing and support functions (engineering, quality, drug product technologies) to provide coordinated support.
- Identify and implement new process improvements to increase reliability, agility, and efficiency.
- Conduct FMEAs and risk assessments; author technical protocols/reports/CMC subsections and present findings.
- Participate in periodic on-call support (evenings/nights/weekends).
- Serve as SME and drive aseptic DP technology/process innovations; design/implement/document primary data packages.
- Support expansion projects (equipment user requirements, FAT, process characterization/validation).
- Support DP network sharing of best practices and act as POC for site process capabilities.
Qualifications:
Basic:
- Master’s degree OR Bachelor’s degree + 2 years Engineering OR Associate’s + 6 years Engineering OR HS/GED + 8 years Engineering.
Preferred:
- Chemical/Biomedical/biotech or related technical background.
- 3+ years in pharma/biotech with process development/characterization and technical transfers.
- Experience with freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, visual inspection.
- Project management; leadership of multifunctional teams; innovation and independent study/protocol/documentation skills.
- GMP/quality systems knowledge; strong communication and technical problem-solving.
Benefits:
- Total Rewards Plan (health/welfare, retirement savings, bonus, stock-based long-term incentives, time-off).
Application instructions:
- Apply via careers.amgen.com; no application deadline; sponsorship not guaranteed.
Responsibilities:
- Provide manufacturing support for aseptic processing operations (technology transfer, process characterization, validation, deviation resolution, continuous process verification).
- Lead and implement on-floor characterization studies (fill recipe development for syringes and vials, process characterization, tech transfer studies, process validation, commercial manufacturing).
- Lead/assist process deviations, exception resolution, and root cause analysis; address issues with drug product processing technologies and equipment.
- Conduct risk assessments and propose/implement CAPA.
- Collaborate with manufacturing and support functions (engineering, quality, drug product technologies) to provide coordinated support.
- Identify and implement new process improvements to increase reliability, agility, and efficiency.
- Conduct FMEAs and risk assessments; author technical protocols/reports/CMC subsections and present findings.
- Participate in periodic on-call support (evenings/nights/weekends).
- Serve as SME and drive aseptic DP technology/process innovations; design/implement/document primary data packages.
- Support expansion projects (equipment user requirements, FAT, process characterization/validation).
- Support DP network sharing of best practices and act as POC for site process capabilities.
Qualifications:
Basic:
- Master’s degree OR Bachelor’s degree + 2 years Engineering OR Associate’s + 6 years Engineering OR HS/GED + 8 years Engineering.
Preferred:
- Chemical/Biomedical/biotech or related technical background.
- 3+ years in pharma/biotech with process development/characterization and technical transfers.
- Experience with freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, visual inspection.
- Project management; leadership of multifunctional teams; innovation and independent study/protocol/documentation skills.
- GMP/quality systems knowledge; strong communication and technical problem-solving.
Benefits:
- Total Rewards Plan (health/welfare, retirement savings, bonus, stock-based long-term incentives, time-off).
Application instructions:
- Apply via careers.amgen.com; no application deadline; sponsorship not guaranteed.