Work Schedule
10 hr shift/nights

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

Job Description

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.

• 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.
• Manages 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.

• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.

• Bachelor's degree required in a scientific field, preferably an engineering field

• 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.
• Suspension Cell Culture Experien
• 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.