Thermo Fisher Scientific · 9 hours ago
Process Engineer II, MSAT
St. Louis, Missouri, USA
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Process Engineer II for their biologics development and manufacturing facility in St. Louis. This role involves providing technical expertise in manufacturing, validation, and process improvement activities in a GMP biologics environment.
Research
No H1B
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
Qualification
Required
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
Strong written and verbal communication skills
Proficiency in Microsoft Word and Excel
Ability to review, analyze, and trend manufacturing and process data
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
Work in a GMP manufacturing environment
Ability to gown into classified areas
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
Preferred
Master's degree may be considered in lieu of some experience
Basic understanding of statistical methods for pharmaceutical process analysis
Benefits
Medical, Dental, and Vision benefits effective Day 1
Paid Time Off and designated paid holidays
Retirement Savings Plan
Tuition Reimbursement
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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