Senior OT Systems Engineer for GMP Manufacturing

Avid Bioservices; 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 design, implementation, and support of enterprise systems and manufacturing equipment within a GMP-regulated environment. You will coach technical staff and collaborate with QA, Engineering, and IT to ensure compliant operations.

The role emphasizes regulated systems expertise, project leadership, and the ability to communicate complex concepts to technical and non-technical audiences while supporting continuous improvement

Qualifications

• Bachelor's degree required; relevant experience may substitute on a year-for-year basis.
• 5–7 years in complex systems design, administration, or regulated equipment support in GMP settings.
• Hands-on with Empower 3, DeltaV, Rockwell, Cytiva UNICORN, Sartorius, Sartocheck platforms.
• Knowledge of 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity principles.
• Ability to plan and execute complex system design and sustainment activities.
• Experience leading projects and mentoring junior engineers.
• Strong written and verbal communication to technical and non-technical audiences.

Responsibilities

• Lead and maintain system admin docs for lab instruments, enterprise systems, and regulated equipment.
• Develop, review, and update design specs, work instructions, and GMP procedures.
• Support test methods and testing activities for lab and manufacturing equipment.
• Provide support for change management, deviations, CAPA, upgrades, and lifecycle activities.
• Perform equipment testing and train staff on software/hardware.
• Provide technical guidance to Operations, Support, and cross-functional teams.
• Lead complex troubleshooting and coordinate vendor engagements for regulated systems.
• Support security policies, access controls, and compliance with regulatory expectations.
• Coordinate project activities to maximize value and minimize operational impact.

Skills

Regulated systems experience

Documentation & compliance

Project leadership

Communication skills

Education

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

Tools

Empower 3

Emerson DeltaV

DeltaV Mobile

Rockwell FactoryTalk

Cytiva UNICORN

Sartorius MFCS/BioBrain

Sartocheck 4/5

Job description

Avid Bioservices in California is seeking a Senior Engineer, OT to lead design, implementation, and support of enterprise systems and manufacturing equipment within a GMP-regulated environment. You will coach technical staff and collaborate with QA, Engineering, and IT to ensure compliant operations.

The role emphasizes regulated systems expertise, project leadership, and the ability to communicate complex concepts to technical and non-technical audiences while supporting continuous improvement