Senior GxP Systems Engineer - GMP Tech Lead

Avid Bioservices, Inc.; Tustin (CA); On-site; USD 94,000 - 117,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices is seeking a Senior Engineer, GxP Systems to lead technical design, planning, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation in a GMP environment. You’ll collaborate with project teams to implement technology solutions that align with regulatory expectations.

The role requires 5–7 years in complex systems in GMP settings, and hands-on experience with Empower 3, DeltaV, and other regulated platforms.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or related field.
• 5–7 years of experience in complex systems design, systems administration, application support, or regulated equipment support in GMP environments.
• Hands-on experience with regulated lab/manufacturing platforms (Empower 3, DeltaV, Rockwell FactoryTalk, Cytiva UNICORN, Sartorius MFCS/BioBrain, Sartocheck 4/5).
• Knowledge of 21 CFR Part 11, GAMP 5, ALCOA+ data integrity concepts.
• Experience leading projects and mentoring junior engineers.
• Ability to communicate complex technical information to technical and non-technical audiences.

Responsibilities

• Lead system administration documentation for laboratory instruments, enterprise systems, and manufacturing equipment.
• Develop, review, and update design specifications, procedures, and support documentation for GMP equipment and processes.
• Support test methods and system testing activities for laboratory and manufacturing equipment.
• Provide technical guidance and documentation support for change control, deviations, CAPAs, upgrades, and lifecycle management.
• Train staff on software/hardware and coordinate with cross-functional teams.
• Lead complex troubleshooting, coordinate vendor engagement, and drive corrective actions for regulated systems.
• Support security policies and access controls for OT environments.
• Coordinate project activities to maximize value and minimize operational impact.

Skills

GxP systems

Regulatory compliance

Technical documentation

Project leadership

Communication

Education

Bachelor's degree in Life Sciences / IT / Engineering

Tools

Empower 3

Emerson DeltaV

DeltaV Mobile

Rockwell FactoryTalk

Cytiva UNICORN

Sartorius MFCS/BioBrain

Sartocheck 4/5

Job description

Avid Bioservices is seeking a Senior Engineer, GxP Systems to lead technical design, planning, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation in a GMP environment. You’ll collaborate with project teams to implement technology solutions that align with regulatory expectations.

The role requires 5–7 years in complex systems in GMP settings, and hands-on experience with Empower 3, DeltaV, and other regulated platforms.