Senior Engineer, GxP Systems

BioTalent; Tustin (CA); On-site; USD 94,000 - 117,000; Full time

Job summary

BioTalent is seeking a Senior Engineer, GxP Systems to lead the design, implementation, and support of enterprise GMP systems, manufacturing equipment, and laboratory instrumentation in a regulated biopharmaceutical environment.

The role requires 5–7 years in systems design/administration, documentation, and regulatory compliance, with hands-on experience in platforms like Empower 3 and DeltaV. On-site in Tustin, CA, with standard business hours and on-call rotation.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or a related discipline
• 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

Responsibilities

• 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

Skills

GxP Systems

GMP Experience

Regulatory Compliance

Documentation

Education

Bachelor's degree in Life Sciences, Computer Science, IT, Engineering

Tools

Empower 3

Emerson DeltaV

FactoryTalk

UNICORN

Sartorius MFCS/BioBrain

Sartocheck

Job description

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

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

Additional compensation and benefits package available

Please Note

On-site in Tustin, CA

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

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

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