Assistant Process Engineer

Position Title: Assistant Process Engineer

Work Location: Devens MA, 01434 - Hybrid

Assignment Duration: 6 months

Work Schedule: Mon-Fri(normal business hours)

Work Arrangement: Minimum 50% onsite

Position Summary: The MSAT Process Engineering Contractor will support Manufacturing Science and Technology (MSAT) activities. There will be a focus on Out-of-Specification (OOS) investigations.

Key Responsibilities:

• Support OOS investigations; may take on investigation ownership as appropriate.
• Review batch records, process data, equipment logs, and analytical results to support investigation findings.
• Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams to gather data and align on investigation scope and conclusions.
• Present investigation findings and technical rationale to cross-functional teams and management as required.

Qualification & Experience:

• Required Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related technical discipline.
• Minimum 0-2 years of industry experience; cGMP or Cell Therapy manufacturing experience.
• Strong technical understanding of cell therapy manufacturing processes(Preferred)
• Technical writing skills for authoring impact assessments and out-of-specification investigations.
• Strong problem-solving, troubleshooting, and presentation skills.
• Familiarity with GMP documentation and electronic data systems.
• Ability to work collaboratively in a fast-paced environment.
• Strong analytical and critical-thinking skills with attention to detail.
• Effective communicator, able to work cross-functionally with Quality, Manufacturing, and Engineering stakeholders.