Assistant Process Engineer - OOS/MSAT Support (Hybrid)

Mindlance; Harvard (MA); Hybrid; USD 55,000 - 83,000; Full time

Job summary

Mindlance seeks a MSAT Process Engineering Contractor/Assistant Process Engineer to support Manufacturing Science and Technology (MSAT) activities at our Devens, MA site, with a focus on Out-of-Specification (OOS) investigations and cross-functional collaboration.

The candidate should have a Bachelor's in Chemical/Biochemical Engineering or Chemistry and up to 2 years of industry experience, plus strong technical writing, analytical, and presentation skills.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related technical discipline.
• 0–2 years of industry experience; cGMP or Cell Therapy manufacturing experience.
• Strong technical writing for 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, cross-functional with Quality, Manufacturing, and Engineering.

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.

Skills

cGMP knowledge

Cell therapy manufacturing

Technical writing

Analytical thinking

Cross-functional communication

Problem solving

Education

Bachelor's degree in Chemical/ Biochemical Engineering or Chemistry

Job description

Mindlance seeks a MSAT Process Engineering Contractor/Assistant Process Engineer to support Manufacturing Science and Technology (MSAT) activities at our Devens, MA site, with a focus on Out-of-Specification (OOS) investigations and cross-functional collaboration.

The candidate should have a Bachelor's in Chemical/Biochemical Engineering or Chemistry and up to 2 years of industry experience, plus strong technical writing, analytical, and presentation skills.