Position Title:

Assistant Process Engineer Work Location:

Devens

MA, 01434

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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.