Sr. Engineer, OT

Avid Bioservices•Tustin, CA

10d•Onsite

About The Position

The Senior Engineer, OT leads the technical design, planning, implementation, administration, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation within a GMP-regulated environment. This role serves as a technical expert for specialized manufacturing, process development, and quality control systems, ensuring platforms operate reliably, securely, and in alignment with applicable policies, procedures, and regulatory expectations. Working with a high degree of independence, the Senior Engineer, OT evaluates system requirements, develops system specifications, and supports recovery and continuity planning. The role partners with project leadership to identify and implement technology and process improvements that support core manufacturing and quality control operations.

Requirements

Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or a related discipline; relevant experience may substitute for the degree requirement on a year-for-year basis.
5 to 7 years of relevant experience in complex systems design, systems administration, application support, technical documentation, or regulated equipment support, including experience in a GMP-regulated manufacturing or laboratory environment.
Hands-on experience with a combination of regulated laboratory and manufacturing platforms such as Empower 3, Emerson DeltaV and DeltaV Mobile, Rockwell FactoryTalk, Cytiva UNICORN, Sartorius MFCS/BioBrain, Sartocheck 4 and 5, or equivalent systems.
Working knowledge of 21 CFR Part 11, GAMP 5, and data integrity principles, including ALCOA+.
Ability to plan, organize, document, and execute complex system design and support activities in alignment with organizational policies, procedures, and compliance expectations.
Experience leading projects and mentoring junior engineers.
Ability to communicate complex technical information clearly to technical and non-technical audiences.
Ability to prioritize competing demands and respond effectively to emergency or production-impacting situations.

Nice To Haves

Experience with Computer System Validation activities, including IQ/OQ/PQ authoring and execution.
Experience with SpectraMax SoftMax Pro, Agilent HPLC, BioTek plate readers, EndoScan-V, Beckman PA800/Plus, Versa Star Pro pH Meter, Endosafe, DU800 UV/Vis, BMRAM, or equivalent systems.
Familiarity with backup, disaster recovery, and business continuity practices for regulated systems, including Veeam, Acronis, or equivalent tools.
Exposure to cybersecurity frameworks relevant to OT environments, such as NIST 800-82 or IEC 62443.
Experience supporting client or regulatory audits and working within a matrixed IT, Engineering, and Quality organization.

Responsibilities

Lead and maintain system administration documentation for laboratory instruments, enterprise systems, manufacturing equipment, and regulated applications to support reliable, compliant operations.
Develop, review, and update design specifications, work instructions, technical procedures, and support documentation for GMP equipment, systems, and processes.
Support the development, modification, and execution of test methods and system testing activities for laboratory and manufacturing equipment.
Provide technical and documentation support for change management, deviation investigations, corrective actions, system upgrades, and lifecycle management activities.
Perform equipment and application testing and train technical staff on developed, upgraded, or acquired software and hardware.
Provide technical guidance, procedures, and training to Operations, Support, Systems Development, vendors, and cross-functional project teams.
Lead complex troubleshooting, coordinate vendor engagement, and drive problem resolution for regulated systems and equipment.
Support security policies, access controls, and procedures designed to protect systems from unauthorized or unintended use.
Coordinate and support project activities to maximize business value, minimize operational impact, and enable successful implementation of technology solutions.