Process Engineering SME-Bio-tech

Job Title: Process Engineering SME Biotech



Location: North Carolina Onsite



Duration: Long-Term Contract



Employment Type: W2 Contract



Pay Rate: $55/hr(DOE)

We are seeking a senior Biotech Process Engineering SME with 10 15+ years of hands-on process engineering/design experience supporting drug substance manufacturing. This position requires strong expertise across both upstream and downstream process design and is specifically focused on engineering design-not validation, CQV, commissioning, or manufacturing operations.

Job Requirements:

• 10 15+ years of biotech process engineering/design experience

• Strong upstream and downstream process design expertise

• Hands-on experience with cell culture, bioreactors, and monoclonal antibody (mAb) manufacturing

• Strong knowledge of drug substance manufacturing processes

• Experience designing and selecting biotech process equipment and systems

• Hands-on development/review of P&IDs, URS, equipment specifications, and Sequence of Operations

• Experience with vendor equipment/component selection and integration

• Ability to develop process design packages from concept through final design/delivery

• Experience collaborating with multidisciplinary engineering teams and external design/engineering firms

• Large-scale biotech facility build, expansion, or retrofit experience is preferred

Important: Candidates whose experience is primarily Validation, CQV/C&Q, Commissioning, or Manufacturing Operations without direct process engineering/design responsibility will not be considered.