Senior QA Process Validation Lead (PPQ & CPV)

INCOG BioPharma Services; Fishers (IN); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Paid vacation days

11 observed holidays

401(k) with company match up to 3.5%

Health and wellness plans

FSA and HSA programs

Dental and vision care

Job summary

INCOG BioPharma Services is seeking a Senior QA Process Validation Engineer, II to provide QA oversight of the three-stage process validation life cycle for aseptically filled drug products at our Fishers, Indiana site.

Responsibilities include designing and approving validation protocols, risk assessments, PPQ studies, and CPV programs; ensuring FDA/EMA/ICH compliance; and leading audits and CAPA activities. A bachelor’s in science/engineering and 5+ years of relevant experience are required.

Qualifications

• Bachelor’s degree in science or engineering or related discipline.
• Minimum 5 years of experience in pharmaceutical/biopharmaceutical manufacturing with process validation involvement.
• Hands‑on design and execution of PPQ studies for aseptically filled products.

Responsibilities

• Provide QA oversight of the three-stage process validation life cycle (Stage 1, Stage 2, Stage 3).
• Review and approve validation documents, risk assessments, CPP/CQA identification, and validation reports.
• Ensure compliance with FDA, EMA, ICH, and internal SOPs across validation activities.
• Oversee change controls and revalidation assessments in a timely manner.
• Participate in development and revision of validation SOPs, policies, and guidance.
• Serve as QA SME during audits and regulatory inspections related to process validation.

Skills

Process validation

PPQ

CPV

Risk assessment

Statistical analysis

Regulatory compliance

Quality systems

Education

Bachelor’s degree in science or engineering

Tools

Minitab

JMP

Job description

INCOG BioPharma Services is seeking a Senior QA Process Validation Engineer, II to provide QA oversight of the three-stage process validation life cycle for aseptically filled drug products at our Fishers, Indiana site.

Responsibilities include designing and approving validation protocols, risk assessments, PPQ studies, and CPV programs; ensuring FDA/EMA/ICH compliance; and leading audits and CAPA activities. A bachelor’s in science/engineering and 5+ years of relevant experience are required.