MSAT Process Engineer (OOS Investigations) - Hybrid

Spectraforce Technologies, Inc.; Harvard (MA); Ibrido; USD 55.000 - 83.000; Tempo pieno

Descrizione del lavoro

Spectraforce Technologies, Inc. is seeking an Assistant Process Engineer to support MSAT activities with a focus on OOS investigations at Devens, hybrid work arrangement.

The contractor will review batch records, data, and logs to support investigation findings and partner with QA/QC, Manufacturing, and Engineering teams to align on scope and conclusions. Ideal candidates hold a Bachelor's degree in a related chemical/biochemical field and have 0-2 years of industry experience, with strong

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Attention to detail

Analytical thinking

Cross-functional communication

Presentation skills

Problem solving

Team collaboration

Formazione

Bachelor's degree in Chemical Engineering / Biochemical Engineering / Chemistry

Descrizione del lavoro

Spectraforce Technologies, Inc. is seeking an Assistant Process Engineer to support MSAT activities with a focus on OOS investigations at Devens, hybrid work arrangement.

The contractor will review batch records, data, and logs to support investigation findings and partner with QA/QC, Manufacturing, and Engineering teams to align on scope and conclusions. Ideal candidates hold a Bachelor's degree in a related chemical/biochemical field and have 0-2 years of industry experience, with strong