Operations Engineer

🚀 Automation & Quality Engineer

📍 Tustin, CA | On-site

🗓 Monday–Friday | 8:00 AM – 5:00 PM

🌱 Support the Technology Behind Life-Saving Biopharmaceutical Manufacturing

🎓 Ideal opportunity for experienced automation, validation, and quality professionals with GMP manufacturing and laboratory systems expertise.

Are you passionate about automation systems, validation, manufacturing technology, and quality compliance ? We're looking for an Automation & Quality Engineer to support manufacturing equipment, laboratory systems, validation activities, and operational technologies within a GMP-regulated biopharmaceutical environment.

🔬 What You'll Do

✔ Support the administration and lifecycle management of manufacturing equipment, automation platforms, and laboratory systems

✔ Develop and maintain technical documentation, validation protocols, procedures, and engineering records

✔ Support system implementation, upgrades, qualification activities, and change control initiatives

✔ Execute and support CSV, CQV, investigations, deviations, CAPAs, and compliance-related activities

✔ Troubleshoot automation systems, manufacturing equipment, and regulated applications

✔ Support DeltaV, FactoryTalk, laboratory systems, and manufacturing technologies to ensure operational readiness

✔ Partner with Quality, Manufacturing, Facilities, Validation, and IT teams to drive compliant operations

✔ Train end users and provide technical support for manufacturing and laboratory systems

✅ What We're Looking For

🎓 Bachelor's degree in Engineering, Computer Science, Life Sciences, Information Technology, or a related discipline; relevant experience may substitute for the degree requirement

🧪 5-7 years of experience supporting automation systems, validation programs, manufacturing systems, or regulated applications within a GMP environment

🧪 Experience with DeltaV, FactoryTalk, Empower, UNICORN, laboratory systems, manufacturing technologies, or similar regulated platforms

🧪 Working knowledge of FDA regulations, 21 CFR Part 11, GAMP 5, and data integrity principles

🧪 Experience supporting system validation, quality compliance, investigations, CAPAs, and change control processes

💰 Compensation

Base Salary: $93,600 - $117,000 annually

✅ Additional compensation and benefits package available

📍 Please Note

✅ On-site in Tustin, CA

✅ Full-time position

✅ Schedule is Monday through Friday, 8:00 AM to 5:00 PM

✅ Participation in an on-call rotation is required

✅ Holidays, weekends, and extended-hour support may be required based on business needs

🚫 No relocation assistance mentioned

🚫 No visa sponsorship information provided

If this sounds like you, or someone in your network, I'd love to connect!

#BiotechJobs #AutomationEngineer #QualityEngineer #CSV #CQV #DeltaV #FactoryTalk #ManufacturingSystems #GMP #LifeSciences #Hiring #TustinCA