Senior GxP Systems Engineer for GMP Manufacturing

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

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.