Process Engineer III - Floor Support
On-siteSt. Louis, Missouri, United States
Job Summary
Troubleshoot technical challenges on the manufacturing floor and act as a technical owner for customer programs in a GMP environment. Lead client projects, manage timelines, and drive engineering initiatives to improve practices and procedures with minimal supervision. Draft, review, and approve Manufacturing Batch Records, validation protocols, process flow diagrams, and automation methods. Provide scientific expertise for GMP deviations by assessing and approving impacts on product quality and process validation. Lead changes to equipment and process design, analyze and trend process data, and provide technical feedback on cross-departmental documents. Collaborate with Operations, Quality Assurance, and scientists to ensure project success while supporting the MSAT team to improve site safety and deliver for customers.
Required Qualifications
- Bachelor's degree required in a scientific field, preferably an engineering field
- 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree in a scientific field + 3 years' experience or Ph.D.)
- Knowledge of current Good Manufacturing Practices and US/EU regulations
- Ability to stand for prolonged periods of time and gown into manufacturing areas
- Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Desired Qualifications
- Intermediate knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus
- Proficient in Microsoft Word and Excel
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