Process Engineer II, Upstream

at  Thermo Fisher Scientific

EDUCATION

• Bachelor’s degree required in a scientific field, preferably an engineering field.
• 2+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master’s degree in a scientific field).
• Or 6 years equivalent 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.
• Ability to work both independently and as part of a team.
• Knowledge of current Good Manufacturing Practices and US/EU regulations.
• Novice 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 Standard Operation Procedures, and Job Aids.
• Collaborate with the process development to assess standardized methodologies and learn 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 guided by supervision.
• Manages internal projects and tasks and assists in leading client projects and managing timelines with support from supervision.
• Actively identify error proofing opportunities and drive engineering initiatives to improve practices and procedures with supervision.
• Provide scientific expertise for GMP deviations by assessing the impact of major deviations on both the product quality and the validation of the process.
• Lead changes to equipment and process design.
• Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.
• Draft Process control documents, campaign summary report and process validation reports
• Reviews, analyzes and trends process data with minimal supervision
• Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
• 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.