Senior OT Systems Engineer – GMP Manufacturing

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

Benefits offered by this job

Health, dental, and vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices, Inc. is seeking an OT Systems Engineer, III to lead design, implementation, and support of enterprise systems and manufacturing equipment in a GMP environment.

You will craft specs, validate methods, and guide changes to ensure compliant operations across lab and production settings. The role requires 5–7 years in complex systems and strong documentation and leadership capabilities, with onsite responsibilities in a regulated biopharma setting.

Qualifications

• Bachelor's degree or higher in a related discipline; position may accept equivalent experience.
• 5–7 years of experience in complex systems design, GMP‑regulated environments, and equipment support.
• Experience with regulated lab/manufacturing platforms and documentation practices.
• Knowledge of 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
• Ability to plan, organize, document, and execute complex system activities.
• Experience leading projects and mentoring junior engineers.
• Clear communication to both technical and non‑technical audiences.

Responsibilities

• Lead system administration documentation for lab instruments, enterprise systems, and manufacturing equipment.
• Develop and update design specs, SOPs, and technical procedures for GMP systems.
• Test methods and system testing for laboratory and manufacturing equipment.
• Support change management, deviations, CAPA, upgrades, and lifecycle activities.
• Provide technical training and guidance to operations, teams, vendors, and project groups.

Skills

GMP familiarity

System design

Regulated equipment support

Documentation

Communication

Project leadership

Mentoring

ALCOA+ data integrity

Education

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

Tools

Empower 3

Emerson DeltaV

Rockwell FactoryTalk

Cytiva UNICORN

Sartorius MFCS/BioBrain

Sartocheck 4/5

Beckman PA800/Plus

Versa Star Pro pH Meter

Job description

Avid Bioservices, Inc. is seeking an OT Systems Engineer, III to lead design, implementation, and support of enterprise systems and manufacturing equipment in a GMP environment.

You will craft specs, validate methods, and guide changes to ensure compliant operations across lab and production settings. The role requires 5–7 years in complex systems and strong documentation and leadership capabilities, with onsite responsibilities in a regulated biopharma setting.