Senior Engineer, GxP Systems

🚀 Senior Engineer, GxP Systems

📍 Tustin, CA | On-site

🗓 Monday–Friday | 8:00 AM – 5:00 PM

🌱 Support the Technology Behind Life-Saving Biopharmaceutical Manufacturing

🎓 Ideal opportunity for experienced GxP Systems professionals with expertise supporting GMP manufacturing equipment, laboratory systems, and regulated applications.

Are you passionate about regulated systems, manufacturing technology, laboratory instrumentation, and compliance-driven environments ? We're looking for a Senior Engineer, GxP Systems to lead the design, implementation, administration, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation within a GMP-regulated biopharmaceutical environment.

🔬 What You'll Do

✔ Lead administration and support activities for manufacturing equipment, laboratory instrumentation, enterprise systems, and regulated applications

✔ Develop, review, and maintain technical documentation, design specifications, procedures, work instructions, and support documentation

✔ Support testing, implementation, upgrades, lifecycle management, and system improvement initiatives

✔ Provide technical support for change controls, deviations, CAPAs, investigations, and regulatory compliance activities

✔ Lead troubleshooting efforts and coordinate with vendors to resolve complex system and equipment issues

✔ Support security controls, access management, and system integrity for regulated platforms

✔ Train technical staff and provide guidance to Operations, Engineering, Quality, and cross-functional teams

✔ Coordinate project activities and technology implementations that support manufacturing and quality control operations

✅ What We're Looking For

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

🧪 5-7 years of relevant experience in systems design, systems administration, application support, technical documentation, or regulated equipment support within a GMP-regulated manufacturing or laboratory environment

🧪 Hands-on experience with regulated laboratory and manufacturing platforms such as Empower 3, Emerson DeltaV, FactoryTalk, UNICORN, Sartorius MFCS/BioBrain, Sartocheck, or equivalent systems

🧪 Working knowledge of 21 CFR Part 11, GAMP 5, and data integrity principles including ALCOA+

🧪 Experience leading projects and mentoring junior engineers

💰 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!

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