Manufacturing Engineer II (Process Expert)
Siegfried · Irvine, CA
CMCFull-time$105k–$120kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Manufacturing Engineer II supporting pharmaceutical production operations at a CDMO. Responsible for process optimization, equipment qualification, GMP documentation, investigations, and continuous improvement across API, formulation, and aseptic fill-finish manufacturing. Role requires 3+ years regulated pharma manufacturing experience and technical expertise in process validation and instrumentation.
What they're looking for
- Bachelor's degree in Engineering, Biological Sciences, or related technical discipline
- 3+ years pharmaceutical, biotechnology, or CDMO manufacturing experience in GMP environment
- Equipment qualification and process validation experience in regulated manufacturing
- Strong technical writing, data analysis, troubleshooting, and problem-solving skills
- Working knowledge of GMP regulations, quality systems, and data integrity requirements
- Ability to manage multiple priorities in fast-paced manufacturing environment
- Strong cross-functional communication and collaboration skills
What you'll be doing
- Provide technical support for GMP pharmaceutical manufacturing operations and troubleshooting
- Own manufacturing documentation including SOPs, batch records, protocols, and technical reports
- Lead equipment qualification activities, process validations, and continuous improvement projects
- Manage production instrumentation including calibration, maintenance, and troubleshooting
- Lead investigations and root cause analyses for manufacturing events and deviations
Privacy & handoff
This role links to Siegfried's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.