PSC Biotech® Corporation · 5 hours ago
Validation Engineer
San Diego, CA
Full-time
Onsite
Mid Level
$90K/yr - $125K/yr
4+ years expPSC Biotech® Corporation is a provider of essential services to the life sciences industry, ensuring compliance with regulatory standards for health care products. The Validation Engineer will support validation activities in a regulated environment, focusing on equipment, processes, and systems to ensure product quality and regulatory compliance.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems
Generate and execute validation documentation for manufacturing equipment, utilities, and computerized systems in accordance with cGMP, GxP, and Annex 11 requirements
Support CQV activities for sterile injectable manufacturing equipment and site utilities, ensuring seamless integration and qualification
Lead CSV efforts, including risk assessments, validation plans, and test scripts for computerized systems to maintain data integrity
Validate and qualify various equipment and utilities i.e Depyrogenation Ovens
Troubleshoot and resolve issues related to validated equipment, processes, and systems; implement CAPA as needed
Maintain accurate validation documentation and ensure audit readiness
Additional responsibilities as assigned to drive project success
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences
4–5 years of validation experience within pharmaceutical, biotech, or medical device industries
Strong knowledge of CSV and CQV principles, including regulatory expectations for sterile injectable manufacturing
Familiarity with Annex 11, data integrity requirements, and industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations
Experience with equipment, cleanroom systems, HVAC, purified water, compressed air, and other critical utilities
Proficiency in writing and executing IQ/OQ/PQ protocols, validation reports, and computerized system validation documentation
Strong analytical and problem-solving skills
Excellent written and verbal communication abilities
Strong time management and organizational skills
Detail-oriented mindset with a commitment to maintaining high-quality standards
Must be authorized to work in the US
No C2C at this time
Benefits
Medical and sick time benefits
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
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