Process Engineer I - Manufacturing Sciences
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. 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. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Location/Division Specific Information
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.
How will you make an impact?
We are searching for a Process Engineer 1 with education in biopharmaceutical processing, or a related field. This member of our team uses their foundational knowledge in general scientific and engineering principles to provide technological input in the scale up and validation of manufacturing processes. A Process Engineer 1 supports the Process Engineering team as technical owners of customer programs in a manufacturing environment and will assist in defining and shaping Thermo Fisher Scientific’s own technology programs. This role will collaborate internally with technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.
What will you do?
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 and 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.
Performs 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.
How will you get here?
Education
Bachelor’s degree required in a scientific field, preferably an engineering field
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.
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 of time and gown into manufacturing areas.