PSC Biotech® Corporation · 19 hours ago
Validation Engineer
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$80K/yr - $90K/yr
3+ years expPSC Biotech® Corporation provides essential services to the life sciences sector to ensure compliance with regulatory requirements for health care products. We are seeking an experienced Validation Engineer to support equipment, process, and facility validation activities in a regulated environment, focusing on ensuring reliability and safety in compliance with cGMP standards.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Generate and execute validation documentation for equipment, utilities, and processes in accordance with cGMP and GxP standards
Support commissioning and qualification (CQV) activities for new and existing systems
Ensure seamless integration and validation of manufacturing equipment lines and facility systems
Troubleshoot and resolve issues related to validated equipment and processes, implementing corrective and preventive actions (CAPA) as needed
Additional responsibilities as assigned to drive project success
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences
3–7 years of validation experience within the pharmaceutical, biotech, or medical device industries
Strong knowledge of equipment and process validation in FDA-regulated environments
Familiarity with industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations
Experience with qualifying manufacturing lines
Proficiency in writing and executing IQ/OQ/PQ protocols and validation reports
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, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
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
Company data provided by crunchbase