Quality Engineer II
Thermo Fisher Scientific · St. Louis, MO
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Quality Engineer II at Thermo Fisher Scientific's St. Louis biologic manufacturing facility evaluates production processes and drives quality improvements in a GMP-regulated environment. The role involves on-site monitoring of manufacturing operations, compliance inspections, and cross-functional collaboration to support clinical and commercial drug substance production.
What they're looking for
- Bachelor's degree in life sciences or engineering, or high school diploma with 5+ years experience
- Substantial prior experience in quality, process engineering, or manufacturing in regulated industries
- Knowledge of GMP compliance, aseptic practices, and contamination control
- Familiarity with audit procedures, deviation management, and change control processes
- Ability to work shift schedules including weekends and on-call rotations
- Strong communication and interpersonal skills for cross-functional collaboration
What you'll be doing
- Monitor manufacturing operations daily and provide quality assurance input to manufacturing and process engineering teams
- Conduct audits, inspections, and GEMBA walks to ensure compliance with cGMP standards and regulatory requirements
- Observe aseptic practices and provide coaching to colleagues on contamination prevention
- Participate in client and regulatory audits as a subject matter expert on procedures and practices
- Review batch records, equipment changeovers, autoclave logs, and fit-and-finish inspections; write and manage deviations and CAPAs
Privacy & handoff
This role links to Thermo Fisher Scientific'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.