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

How will you make an impact?

We are seeking a Process Engineering Supervisor with expertise in biologics processing. This role involves providing technological input in the development, validation, and transfer of manufacturing processes. The Supervisor, Manufacturing Sciences is responsible for guiding customer programs and shaping Thermo Fisher Scientific’s technology programs. Collaboration with different functional areas is crucial for project success.

What will you do?

Lead a team of engineers to facilitate process execution through creation of detailed Process Flow Diagrams, Standard Operation Procedures, and Job Aids.Collaborate with process development to develop standardized methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, chromatography, ultrafiltration, and depth filtration.Facilitate Internal and Customer meetings based upon sound evidence.Lead group projects and manage timelines with support from supervision as needed.Actively identify and drive engineering initiatives to improve practices and procedures.Devise and Implement Corrective and Preventative Actions.Lead changes to equipment and processes as an authority.Review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, and Technical Reports, ensuring the process is technically accurate and designed for Manufacturing.Provide technical feedback on documents built by other departments, such as Tech Transfer Protocols and SOPs.Consult on 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 mentorship for Process Engineers/Scientists.

How will you get here?

Education and Experience

Bachelor’s degree required in a scientific field, preferably an engineering field, plus 4 years of biotechnology or pharmaceutical industry 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.Knowledge of current Good Manufacturing Practices and US/EU regulations.Knowledge of statistical methods used for Pharmaceutical Process AnalysisProficient in Microsoft Word and Excel.Ability to stand for long periods of time and gown into manufacturing areas.