Validation Engineer

🚀 WE’RE HIRING | Validation Engineer I

📍 Tustin, California | Onsite

Looking to make an impact in the biopharmaceutical industry? Join Avid Bioservices , a leading clinical and commercial biologics CDMO dedicated to developing and manufacturing life-saving therapies!

🔬 What You'll Do:

• Support commissioning, qualification, and validation (CQV) activities for GMP equipment, utilities, facilities, and computerized systems.
• Develop, execute, and document validation protocols and final reports, including IQ/OQ/PQ activities.
• Review User Requirement Specifications (URS), equipment specifications, engineering drawings, P&IDs, calibration records, and vendor documentation.
• Perform temperature mapping and requalification of GMP equipment, including autoclaves, depyrogenation ovens, refrigerators, freezers, and temperature-controlled chambers.
• Conduct gap analyses of vendor protocols and evaluate qualification data to ensure compliance with approved acceptance criteria.
• Coordinate validation activities with Quality Assurance, Manufacturing, Facilities, Engineering, Supply Chain, and external vendors.
• Maintain accurate validation documentation in accordance with cGMP requirements, FDA regulations, EU GMP guidelines, and GAMP 5 principles.

🎯 What We're Looking For:

• Bachelor's degree in Biology, Microbiology, Biochemistry, Chemistry, Engineering, Computer Science, or a related technical field.
• 2–4 years of experience in validation or a related pharmaceutical/biotechnology industry.
• Familiarity with equipment qualification, utility validation, IQ/OQ/PQ execution, and GMP documentation practices.
• Experience in FDA-regulated or other regulated manufacturing environments is preferred.
• Experience with temperature mapping systems such as Ellab ValSuite, Lives, or similar tools.
• Strong analytical, organizational, communication, and problem-solving skills, with excellent attention to detail.

We offer:

✅ Competitive hourly compensation

✅ Performance-based bonuses

✅ Health, dental & vision insurance

✅ 401(k) matching

✅ Paid time off

✅ Career growth and development opportunities

Work Authorization:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time

f you have experience connecting technical materials management with GMP manufacturing , I'd love to hear from you!

📩 Interested or know someone who may be a great fit? Send me a message or apply today.

#Hiring #MSAT #Biopharma #Biotechnology #Manufacturing #RawMaterials #GMP #CDMO #LifeSciences #Engineering #Tustin #California #Biologics

The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process,

Apply, and please feel free to reach out.

If you're passionate about biopharmaceutical manufacturing, employee development, and building a strong GMP culture , I'd love to connect!