Validation Engineer

PSC Biotech • Irvine, CA

1d • $80,000 - $90,000

About The Position

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring an experienced Validation Engineer to support equipment, process, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP and regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance.

Requirements

• 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.

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.

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