Location
Waltham, Massachusetts
Job Type
Full-time
Posted
May 14, 2026
Job Description
Job Description:
Roles & Responsibilities:
- We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment.
- This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV).
Roles & Responsibilities:
- Perform validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment
- Ensure compliance with GMP and 21 CFR Part 11 standards
- Develop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization procedures
- Conduct equipment qualification activities (IQ/OQ/PQ) and ongoing perform...