Hiring: Sr. Engineer, OT Company: Avid Bioservices Location: Tustin, CA Job Posted Time: 2026-09-03 10:33:21 Employment Type: Full-time Target Skills & Keywords : Design System, Systems Design About the job Experience: •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. •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. Required Skills: •Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. •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. •Actively facilitate and support 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. Qualifications: •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. •Applied hands-on capability in 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. •Solid functional working knowledge of 21 CFR Part 11, GAMP 5, and data integrity principles, including ALCOA+. •Demonstrated capacity to plan, organize, document, and execute complex system design and support activities in alignment with organizational policies, procedures, and compliance expectations. •Demonstrated capacity to communicate complex technical information clearly to technical and non-technical audiences. •Demonstrated capacity to prioritize competing demands and respond effectively to emergency or production-impacting situations. •Operational 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. •This role is a full-time onsite position. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours as needed. This position includes participation in an on-call rotation to provide support outside of regular business hours. Compensation: •$93,600 - $117,000 / year •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!