Specialist Manufacturing - Production Process Owner
Amgen
8 days ago
On-site
Thousand Oaks, CA
Operations
Specialist Manufacturing - DP Production Process Owner (Thousand Oaks, ATO)
What You Will Do
- Ensure commercial and clinical Drug Product/Visual Inspection operations are compliant, efficient, and continuously improving.
- Partner cross-functionally (Engineering, Quality, Process Development, Operations) to implement improvements, support new technology introductions, and maintain GMP performance.
Key Responsibilities
- Change control & continuous improvement: support GMP/regulatory compliance; evaluate/justify process/equipment changes; enhance safety/quality/efficiency.
- Process implementation & project execution: implement new processes/equipment/initiatives; collaborate to define requirements and readiness; develop/implement SOPs, batch records, training, validation, and automation configurations.
- Operational performance & analytics: analyze data/metrics; develop data-driven solutions to improve yield/reliability/compliance; support monitoring (Enterprise Data Lake, Spotfire).
- Deviation & CAPA: investigate deviations; support RCA/human performance; develop/implement CAPAs and monitor effectiveness.
- Validation & process control: support validation protocols/reports; analyze validation/monitoring data; support parameters/control limits/reporting.
- Documentation & process management: initiate/revise/approve controlled documents in CDOCs; act as author/owner/reviewer/verifier; maintain GMP-accurate documentation.
Qualifications
- Basic: Doctorate OR Master’s + 2 yrs manufacturing support OR Bachelor’s + 4 yrs OR Associate’s + 8 yrs OR HS/GED + 10 yrs.
- Preferred: Master’s/PhD; aseptic DP/biologics experience; AVI/MVI experience; knowledge of validation/deviations/change control; strong analytics (Spotfire/JMP/Excel); excellent communication and cross-functional collaboration.
Benefits (Total Rewards Plan, if eligible)
- Retirement & Savings with company contributions; medical/dental/vision; life/disability; flexible spending; annual bonus/incentives; stock-based long-term incentives; time-off; flexible work models where possible.
Application
- Apply now via careers.amgen.com. No application deadline; applications accepted until candidate selection.
What You Will Do
- Ensure commercial and clinical Drug Product/Visual Inspection operations are compliant, efficient, and continuously improving.
- Partner cross-functionally (Engineering, Quality, Process Development, Operations) to implement improvements, support new technology introductions, and maintain GMP performance.
Key Responsibilities
- Change control & continuous improvement: support GMP/regulatory compliance; evaluate/justify process/equipment changes; enhance safety/quality/efficiency.
- Process implementation & project execution: implement new processes/equipment/initiatives; collaborate to define requirements and readiness; develop/implement SOPs, batch records, training, validation, and automation configurations.
- Operational performance & analytics: analyze data/metrics; develop data-driven solutions to improve yield/reliability/compliance; support monitoring (Enterprise Data Lake, Spotfire).
- Deviation & CAPA: investigate deviations; support RCA/human performance; develop/implement CAPAs and monitor effectiveness.
- Validation & process control: support validation protocols/reports; analyze validation/monitoring data; support parameters/control limits/reporting.
- Documentation & process management: initiate/revise/approve controlled documents in CDOCs; act as author/owner/reviewer/verifier; maintain GMP-accurate documentation.
Qualifications
- Basic: Doctorate OR Master’s + 2 yrs manufacturing support OR Bachelor’s + 4 yrs OR Associate’s + 8 yrs OR HS/GED + 10 yrs.
- Preferred: Master’s/PhD; aseptic DP/biologics experience; AVI/MVI experience; knowledge of validation/deviations/change control; strong analytics (Spotfire/JMP/Excel); excellent communication and cross-functional collaboration.
Benefits (Total Rewards Plan, if eligible)
- Retirement & Savings with company contributions; medical/dental/vision; life/disability; flexible spending; annual bonus/incentives; stock-based long-term incentives; time-off; flexible work models where possible.
Application
- Apply now via careers.amgen.com. No application deadline; applications accepted until candidate selection.