Sr. Process Engineer - Upstream

at  Thermo Fisher Scientific

EDUCATION

• Bachelor’s degree required in a scientific field, preferably an engineering field.
• 8+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master’s degree in a scientific field + 6 years’ experience or Ph.D + 3 years’ experience.).

EXPERIENCE

• Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment.
• Ability to self-motivate, prioritize work and time.
• Demonstrates a foundation in general scientific practices, principles, and concepts.
• Writes and communicates effectively.
• Experience drafting, reviewing, and approving Manufacturing Batch Records, Process Validation Protocols, process flow diagrams, automation methods, Bill of Materials, Process Control Documents, Campaign Summary Report and Process Validation Reports.
• Ability to work both independently and as part of a team.
• Knowledge of current Good Manufacturing Practices and US/EU regulations.
• Advanced understanding of risk assessments and data mining (excel/JMP).
• Advanced knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus.
• Proficient in Microsoft Word and Excel.
• Ability to stand for prolonged periods of time and gown into manufacturing areas.

• Draft, review and approve Standard Operation Procedures, and Job Aids and consult internally to ensure scientifically sound and robust procedures.
• Collaborate with the process development to develop standardized methodologies and learn/explore/initiate new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
• Contribute to Internal and Customer meetings based upon sound evidence without supervision.
• Initiate and lead internal projects and lead client projects and manage timelines with minimal support from supervision.
• Actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures without supervision.
• Provide scientific expertise for GMP deviations by assessing, reviewing and approving the impact of major deviations on both the product quality and the validation of the process or consults the process engineering team and internal teams on product impact.
• Initiate and lead changes to equipment and process design, proactively and without supervision. Consult on non-standard/challenging process design and/or validation strategies.
• Acts as subject matter expert to troubleshoot design flaws, ensure process design is scientifically sound and robust and within the validated process and regulatory guidelines.
• Reviews, analyzes, and trends process data without supervision.
• Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
• Applies technical and functional knowledge to site projects and is able design experiments (XPs), assist in project design, and independently complete work within own discipline and ensure deliverables against project timelines.
• Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility.
• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.
• Provides development and training for Process Engineers/Scientists.