Validation Engineer

PSC Biotech • Irvine, CA

9d • $75,000 - $125,000

About The Position

Our Validation Engineers support the full CQV lifecycle, ensuring facilities, utilities, equipment, computerized systems, and manufacturing processes are designed, installed, operated, and maintained in compliance with FDA, EU, and global GxP regulations. This role plays a critical part in reducing compliance risks and enhancing operational performance while executing high -quality validation deliverables, providing technical expertise, and supporting regulatory readiness.

Requirements

• 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.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level