Senior OT Engineer - GMP Systems & Lab Tech Leadership

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

Job summary

Avid Bioservices in California is seeking a Senior Engineer, OT to lead the design, planning, implementation and support of enterprise systems, manufacturing equipment, and laboratory instrumentation in a GMP environment. This role requires hands-on expertise with regulated platforms and strong documentation practices.

You will collaborate with cross-functional teams, mentor junior engineers, and participate in audits, validation, and change control to ensure compliant, reliable operations.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering or related discipline (experience may substitute for degree).
• 5–7 years of experience in complex systems design, systems administration, application support, or regulated equipment support in GMP environments.
• Hands-on experience with Empower 3, Emerson DeltaV/DeltaV Mobile, Rockwell FactoryTalk, Cytiva UNICORN, Sartorius MFCS/BioBrain, Sartocheck 4/5, or equivalent systems.
• Working knowledge of 21 CFR Part 11, GAMP 5, and data integrity principles including ALCOA+.
• Ability to plan, document, and execute complex system design and support activities; lead projects and mentor junior engineers.
• Strong communication skills to convey technical information to diverse audiences.

Responsibilities

• Lead design, planning, implementation, administration and support of enterprise systems and regulated equipment in GMP settings.
• Develop specifications, procedures, and documentation for GMP equipment and processes.
• Support test method development, system testing, and lifecycle management activities.
• Provide guidance and training to Operations, Systems, vendors, and cross-functional teams.
• Lead troubleshooting, coordinate vendor engagements and ensure compliant operations.
• Support security, access controls, and change management activities.
• Coordinate project activities to maximize value and minimize operational impact.

Job description

Avid Bioservices in California is seeking a Senior Engineer, OT to lead the design, planning, implementation and support of enterprise systems, manufacturing equipment, and laboratory instrumentation in a GMP environment. This role requires hands-on expertise with regulated platforms and strong documentation practices.

You will collaborate with cross-functional teams, mentor junior engineers, and participate in audits, validation, and change control to ensure compliant, reliable operations.