Validation Engineer III
About The Position
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Job Summary We are looking for a Validation Engineer III to support qualification and validation of facilities, utilities, equipment, analytical systems, and computerized systems used in the manufacture of cGMP protein-based therapeutics, including cell and gene therapies. This role plays a key part in ensuring systems remain compliant, inspection-ready, and aligned with regulatory and quality standards. The Validation Engineer III partners closely with Engineering, Operations, Quality, and customer project teams to execute validation strategies, support continuous improvement, and maintain a strong state of compliance across the site.
Requirements
- Bachelor’s degree with 8+ years of relevant validation experience, or Master’s degree with 6+ years of relevant experience.
- Experience validating facilities, utilities, equipment, and computerized systems in a cGMP environment.
- Strong knowledge of GMP, ICH, and ISO requirements.
- Experience with change control, deviations, investigations, and CAPA processes.
- Experience supporting regulatory inspections and audits.
- Strong organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced, regulated environment.
- Collaborative, team-oriented mindset with attention to detail.
Responsibilities
- Lead and execute equipment, facility, utility, and system validation activities.
- Prepare and execute IQ/OQ/PQ protocols for manufacturing equipment, analytical instruments, facilities, and utilities (e.g., HVAC, BAS, compressed air, nitrogen).
- Support commissioning and engineering studies related to new and existing systems.
- Generate and review qualification reports and validation documentation for internal and regulatory use.
- Manage requalification activities in support of change control.
- Initiate and support deviations, change controls, and CAPAs related to validation activities.
- Develop and maintain validation traceability matrices and GMP criticality assessments.
- Analyze validation data and ensure documentation meets Good Documentation Practices and regulatory requirements.
- Partner with Quality, Engineering, and Operations to define validation strategies and ensure inspection readiness.
- Support investigations and risk assessments related to equipment and process validation.
- Identify and propose remediation for validation gaps or compliance risks.
- Provide validation and quality expertise to internal teams and customer projects.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
