Job Title: Validation Engineer - Sterile Manufacturing Equipment
Position Overview
Our client is seeking an experienced Validation Engineer to support the transition of their GMP sterile manufacturing facility from Restricted Access Barrier Systems (RABS) to Vaporized Hydrogen Peroxide (VHP) sterile isolator technology. This role will be instrumental in validating new aseptic equipment and systems, including those supporting steam-in-place (SIP) and terminal sterilization processes.
Key Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for new equipment, including:
- VHP sterile isolators
- Lyophilizers
- Fillers and cappers
- Manual and automated inspection machines
- Ensure validation activities comply with cGMP regulations, FDA and EU requirements, and internal quality standards
- Participate in commissioning and qualification (C&Q) efforts during equipment installation
- Support FAT/SAT, calibration, and equipment troubleshooting as needed
- Collaborate with engineering, quality, and manufacturing teams to ensure readiness for commercial operations
- Document validation activities with strong attention to detail and in accordance with Good Documentation Practices (GDP)
- Assist in risk assessments, change control processes, and deviation investigations related to equipment validation
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- 7-10 years of experience in equipment validation in GMP-regulated pharmaceutical or biotech environments
- In-depth knowledge of aseptic processing, VHP isolator systems, SIP, and terminal sterilization
- Experience supporting the implementation and validation of new sterile manufacturing equipment