Senior Quality Process Validation Lead – Sterile Injectable

INCOG BioPharma Services; Fishers (IN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Smoke-free campus

Job summary

A leading biopharmaceutical company in Fishers, IN, is seeking a Senior Quality Process Validation Specialist responsible for QA oversight of the three-stage process validation life cycle for aseptically filled drug products. The successful candidate will have a strong background in regulatory compliance, demonstrated experience in process validation, and will participate in audits and inspections. This role values hands-on ownership of protocol design and execution. Join a vibrant team focused on delivering quality outcomes in the pharmaceutical industry.

Qualifications

• 5+ years of experience in pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience designing and executing process validation protocols.
• Understanding of FDA and EMA regulatory requirements.

Responsibilities

• Provide QA oversight and approval of process validation activities.
• Review and approve process validation life cycle documents.
• Ensure compliance with FDA, EMA, and internal requirements.

Skills

Process validation protocols

Risk assessments

Regulatory compliance

Statistical process monitoring

Critical process parameter (CPP)

Education

Bachelor’s degree in a science or engineering field

Tools

Minitab

JMP

Job description

A leading biopharmaceutical company in Fishers, IN, is seeking a Senior Quality Process Validation Specialist responsible for QA oversight of the three-stage process validation life cycle for aseptically filled drug products. The successful candidate will have a strong background in regulatory compliance, demonstrated experience in process validation, and will participate in audits and inspections. This role values hands-on ownership of protocol design and execution. Join a vibrant team focused on delivering quality outcomes in the pharmaceutical industry.