Senior Aseptic Process Validation QA Engineer

INCOG BioPharma; Fishers (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

INCOG BioPharma in Fishers, IN is seeking a Senior QA Process Validation Engineer II to provide QA oversight of the three-stage process validation lifecycle (Stage 1 Design, Stage 2 PPQ, Stage 3 CPV) for aseptically filled drug products.

You will design and review validation protocols and reports, support audits, CAPA, deviation investigations, and ensure compliance with FDA/EMA/ICH guidelines, with emphasis on CPP/CQA identification and lifecycle documentation.

Qualifications

• Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in process validation activities.
• Hands-on experience designing and executing process validation protocols for aseptically filled drug products.
• Familiarity with FDA 2011 Process Validation Guidance, ICH Q8-Q12, and related regulatory expectations.
• Experience with CPP/CQA identification and statistical process monitoring.

Responsibilities

• Provide QA oversight and approval of process validation activities across Stage 1, Stage 2, and Stage 3.
• Review and approve validation life cycle documents including risk assessments, CPP/CQA identification, protocols, and reports.
• Ensure compliance with FDA, EMA, ICH guidelines and internal SOPs.
• Oversee process-related change controls and revalidation assessments.
• Support audits/regulatory inspections related to process validation and CPV.

Skills

Process validation

Aseptic manufacturing

Statistical process monitoring

Lifecycle documentation

Education

Bachelor’s degree in science or engineering

Tools

Minitab

JMP

Job description

INCOG BioPharma in Fishers, IN is seeking a Senior QA Process Validation Engineer II to provide QA oversight of the three-stage process validation lifecycle (Stage 1 Design, Stage 2 PPQ, Stage 3 CPV) for aseptically filled drug products.

You will design and review validation protocols and reports, support audits, CAPA, deviation investigations, and ensure compliance with FDA/EMA/ICH guidelines, with emphasis on CPP/CQA identification and lifecycle documentation.