PSC Biotech® Corporation · 1 day ago
Validation Engineer
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$75K/yr - $125K/yr
3+ years expPSC Biotech® Corporation provides essential services to the life sciences industry, ensuring compliance with regulatory requirements for healthcare products. The Validation Engineer will support the full CQV lifecycle, ensuring systems and processes meet compliance standards while executing high-quality validation deliverables and providing technical expertise.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Responsible for the planning, commissioning, qualification, and validation activities for required cGMP manufacturing and lab equipment, utilities, and computerized systems
Author, review, and execute validation deliverables including but not limited to validation plans, design specifications, user requirement specifications, risk assessments, DQ, IQ, OQ, PQ generation and testing, summary and final reporting
Perform system readiness assessments and verification testing
Ensure systems meet user requirements, functional specifications, and data integrity expectations
Manage system implementation activities including configuration, backup/restore, and periodic reviews
Write, review, and approve SOPs; ensure documentation is accurate, traceable, audit-ready, and compliant
Participate in deviation investigations, root cause analysis, and support CAPA implementation and change control processes
Provide user training and ongoing technical support
Collaborate with cross-functional teams to align on technical functions, deliverables, and quality events
Additional responsibilities as required to drive project success
Qualification
Required
Bachelor's degree in engineering or related technical discipline
3–10 years of experience in validation within GMP-regulated environments (pharmaceutical or biotech)
Hands-on experience validating GxP manufacturing and lab based equipment, analytical instruments, and associated computerized systems
Strong understanding of full lifecycle validation and risk-based approach
Well-versed in regulatory requirements and guidelines (FDA, EMA, ICH, cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11)
Experienced with traceability, change control, deviation handling, and CAPA management
Strong technical writing and documentation skills
Excellent attention to detail, problem-solving, and analytical skills
Ability to manage multiple projects and timelines
Willingness to travel as needed for project assignments and client engagements
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