GMP Process Investigator – OOS/Deviation (MSAT)

Dexian; Acton (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Dexian is seeking an MSAT Process Engineering Contractor to support GMP manufacturing investigations, focusing on OOS and deviation investigations. The role involves reviewing batch records, process data, equipment logs, and analytical results, while collaborating with QA, QC, Manufacturing, and Engineering teams.

The ideal candidate has 2+ years of industry experience, a relevant Bachelor's degree, and strong technical writing and problem-solving skills.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or a related technical field.
• Minimum 2 years of industry experience.
• Experience in a cGMP environment or cell therapy manufacturing.
• Strong technical writing and documentation skills.
• Experience with OOS investigations, troubleshooting, and problem-solving.

Responsibilities

• Support and, when appropriate, take ownership of OOS investigations.
• Review batch records, process data, equipment logs, and analytical results.
• Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams.
• Gather and analyze data to determine investigation scope and conclusions.
• Prepare technical documentation, including investigation reports and impact assessments.
• Present investigation findings and technical rationale to cross-functional teams and management.

Skills

Technical writing

Problem-solving

Analytical thinking

Cross-functional collaboration

Communication

Quality systems

Education

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related field

Tools

Electronic data systems

Job description

Dexian is seeking an MSAT Process Engineering Contractor to support GMP manufacturing investigations, focusing on OOS and deviation investigations. The role involves reviewing batch records, process data, equipment logs, and analytical results, while collaborating with QA, QC, Manufacturing, and Engineering teams.

The ideal candidate has 2+ years of industry experience, a relevant Bachelor's degree, and strong technical writing and problem-solving skills.