Process Engineer I - Manufacturing Sciences

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values—Integrity, Intensity, Innovation, and Involvement—working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

About the Role

Thermo Fisher Scientific's facility in St. Louis, MO, offers comprehensive services for developing and manufacturing biologic drugs. The 96,875-square-foot facility supports the entire process, from initial development to commercial production. It has extensive cell culture capabilities and can handle batch sizes from 100 grams to 20 kilograms using advanced single-use equipment. The site is a leader in single-use technology, providing flexible options for scaling up production from 50 liters to 5,000 liters. The new 5,000-liter Dynadrive bioreactor, developed at the facility, showcases Thermo Fisher's expertise in biologics manufacturing and bioprocessing.

We are searching for a Process Engineer 1 with education in biopharmaceutical processing or a related field. This role uses foundational knowledge in general scientific and engineering principles to provide technological input in the scale-up and validation of manufacturing processes. As technical owners of customer programs in a manufacturing environment, you will assist in defining and shaping Thermo Fisher Scientific’s own technology programs.

Responsibilities

• Collaborate with process development to assess and learn new methodologies for conducting unit operations at the manufacturing scale, including cell culture, harvest, and purification.
• Demonstrate initiative, attention to detail, and an eagerness to learn new systems and technologies.
• Attend internal and customer meetings guided by supervision; may occasionally present data.
• Manage internal projects and tasks on time.
• Actively identify error-proofing opportunities and participate in driving engineering initiatives to improve practices and procedures.
• Provide scientific input for GMP minor deviations.
• Support mock and quality audits.
• Participate in changes to equipment and process design.
• Draft 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.
• Perform daily data monitoring and data collection.
• Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility, including scheduled on-call support activities and occasional weekend coverage.
• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.

Requirements

• Bachelor’s degree required in a scientific field, preferably an engineering field.
• Follow Environmental, Health, and Safety policies and procedures to ensure a safe and healthy workplace environment.
• Ability to self-motivate, prioritize work, and manage time effectively.
• Demonstrates a foundation in general scientific practices, principles, and concepts.
• Strong written and verbal communication skills.
• Ability to work both independently and as part of a team.
• Knowledge of current Good Manufacturing Practices (GMP) and US/EU regulations.
• Fundamental knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus.
• Proficient in Microsoft Word and Excel.
• Ability to stand for prolonged periods and gown into manufacturing areas.

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.
• Cleanroom environment: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• Office environment.
• Some degree of PPE (Personal Protective Equipment) required, including safety glasses, gowning, gloves, lab coat, and ear plugs.

Schedule

Standard (Mon-Fri). Includes scheduled on-call support activities and occasional weekend coverage for a 24/7 manufacturing facility.