Process Engineer II, MSAT

Thermo Fisher Scientific•St. Louis, MO

2d•Onsite

About The Position

Process Engineer II, MSAT Division/Site Specific Information Our St. Louis, MO biologics development and manufacturing facility is a recognized Center of Excellence for bioprocessing and single-use technology (S.U.T.). The site features the Bioprocessing Collaboration Center (BCC) and the Thermo Scientific™ HyPerforma™ DynaDrive™ Single-Use Bioreactors (S.U.B.s). Here, our experts work with high-capital equipment and advanced resources to create customized and optimized process development and scale-up solutions for bispecifics, Fc-fusion proteins, IgG1, IgG4, and other complex protein-based biologics. This environment supports innovation, technical ownership, and close collaboration across manufacturing, development, and quality teams. Discover Impactful Work At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. As part of our global team of 100,000+ colleagues, you’ll work alongside experts driven by our values of Integrity, Intensity, Innovation, and Involvement. As a Process Engineer II, MSAT, you will play a critical role in supporting customer programs and internal technology initiatives by providing technical expertise across manufacturing, validation, and process improvement activities in a GMP biologics environment.

Requirements

Bachelor’s degree required in a scientific discipline; engineering preferred
2+ years of experience in a GMP-regulated biologics or pharmaceutical manufacturing environment
Working knowledge of current Good Manufacturing Practices (cGMPs) and US/EU regulations
Experience supporting manufacturing, validation, or MSAT activities
Knowledge Foundation in general scientific principles and pharmaceutical manufacturing practices
Skills Strong written and verbal communication skills
Proficiency in Microsoft Word and Excel
Ability to review, analyze, and trend manufacturing and process data
Abilities Ability to self-motivate, prioritize, and manage time effectively
Ability to work independently and collaboratively in cross-functional teams
Ability to gown and work in manufacturing environments and stand for prolonged periods
Ability to support a 24/7 manufacturing operation, including on-call and weekend coverage as needed
Must be legally authorized to work in the United States now and in the future without sponsorship
Must be able to pass a comprehensive background check, including drug screening

Nice To Haves

Master’s degree may be considered in lieu of some experience
Basic understanding of statistical methods for pharmaceutical process analysis (preferred)

Responsibilities

Draft and maintain Standard Operating Procedures (SOPs) and Job Aids
Collaborate with Process Development to assess standardized methodologies and learn new unit operations at manufacturing scale (cell culture, harvest, purification)
Contribute to internal and customer meetings, supported by data and sound scientific rationale
Manage internal projects and support client projects, including timeline management
Identify error-proofing opportunities and drive engineering improvements to practices and procedures
Provide scientific and technical support for GMP deviations, assessing impact to product quality and process validation
Lead changes to equipment and process design
Draft, review, and approve: Manufacturing Batch Records Performance Qualifications (PQs) Process Validation protocols Process Flow Diagrams Automation methods Bills of Materials (BOMs)
Draft process control documents, campaign summary reports, and process validation reports
Review, analyze, and trend process data with minimal supervision
Provide technical feedback on documents from other departments (e.g., Tech Transfer Protocols, SOPs)
Troubleshoot technical issues on the manufacturing floor, including on-call support and occasional weekend coverage
Support site-wide MSAT initiatives focused on patient safety, compliance, and customer delivery
Provide development and training support for Process Engineers and Scientists