Operational Technology Engineer/Sr. Engineer
Crystal IS
IT
Fremont, CA, USA
USD 100k-120k / year
Posted on Feb 13, 2026
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company:
Job Description:
Company Summary:
Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.
Position Summary:
The Operational Technology (OT) Engineer is responsible for maintaining, supporting, and improving Bionova’s OT environment across Process Development, Manufacturing, Quality, and supporting functions. This role will perform day to day support for GxP production enterprise systems, maintain operational technology infrastructure, develop comprehensive policies, procedures, and SOPs for the technology department. This role requires a blend of technical expertise, regulatory knowledge, flexibility, and strong communication skills to support the facility's OT infrastructure while maintaining compliance with GMP standards.
Essential Duties and Responsibilities:
• Administrate, maintain, configure, support, troubleshoot, and document Operational Technology infrastructure and applications for GxP manufacturing and process development
environments (ex. UNICORN, Labvantage, AVEVA/Wonderware, BMRAM, and more).
• Implement and integrate new technologies or improve existing technologies to modernize and improve workflows for increasing operational efficiencies as needed for all business functions.
• Install, make changes, repair and provide technical support for computer hardware, software, servers, network equipment, and applications for GxP manufacturing and process development environments.
• Manage and meet security standards and practices for OT infrastructure as defined by internal or external governing bodies.
• Support deployment, validation readiness, and lifecycle management of OT systems including software and licensing.
• Design, build, and maintain internal business applications, tools, and workflows to improve
efficiency, data visibility, and cross-functional coordination.
• Identify opportunities to automate manual processes and reduce operational friction.
• Partner with stakeholders to translate business needs into scalable technical solutions.
• Support GMP, data integrity (DI), and audit readiness for OT systems.
Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.
Position Summary:
The Operational Technology (OT) Engineer is responsible for maintaining, supporting, and improving Bionova’s OT environment across Process Development, Manufacturing, Quality, and supporting functions. This role will perform day to day support for GxP production enterprise systems, maintain operational technology infrastructure, develop comprehensive policies, procedures, and SOPs for the technology department. This role requires a blend of technical expertise, regulatory knowledge, flexibility, and strong communication skills to support the facility's OT infrastructure while maintaining compliance with GMP standards.
Essential Duties and Responsibilities:
• Administrate, maintain, configure, support, troubleshoot, and document Operational Technology infrastructure and applications for GxP manufacturing and process development
environments (ex. UNICORN, Labvantage, AVEVA/Wonderware, BMRAM, and more).
• Implement and integrate new technologies or improve existing technologies to modernize and improve workflows for increasing operational efficiencies as needed for all business functions.
• Install, make changes, repair and provide technical support for computer hardware, software, servers, network equipment, and applications for GxP manufacturing and process development environments.
• Manage and meet security standards and practices for OT infrastructure as defined by internal or external governing bodies.
• Support deployment, validation readiness, and lifecycle management of OT systems including software and licensing.
• Design, build, and maintain internal business applications, tools, and workflows to improve
efficiency, data visibility, and cross-functional coordination.
• Identify opportunities to automate manual processes and reduce operational friction.
• Partner with stakeholders to translate business needs into scalable technical solutions.
• Support GMP, data integrity (DI), and audit readiness for OT systems.
• Assist with SOP development, system documentation, and change management.
• Participate in audits, inspections, and internal reviews as needed.
• Manage purchasing, inventory, and distribution for OT supplies, consumables, and equipment.
• Provide training and guidance to users on OT systems and tools. Support creating work
Instructions including multimedia and infrastructure to train staff and other employees on
common tasks (navigating applications, configuring equipment)
• Work closely with the quality team to manage, write, or own IT-related CAPAs, SOPs, policies, MOCs, work instructions, and deviations.
• Perform periodic access and audit trail reviews for systems.
• Manage backup and disaster recovery procedures for OT systems, including periodic restore testing and documentation.
• Support regulatory inspections and audits by providing system documentation, audit trails, and technical explanations to auditors as needed.
• Other activities as assigned by manager
Working Conditions:
• This position is required to work in a lab/office setting. The role requires walking, standing,
stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 40
pounds independently.
• This is an on-site position, working standard business hours on site,5 days a week.
• This role requires availability for on-call support during weekends or off-hours to address critical OT issues.
• We have multiple work sites, most within a mile of each other. Reliable transportation (personal vehicle) is required to move between locations as needed. Occasional long-distance travel may be required (Under 20%).
• Our facility includes GMP (Good Manufacturing Practice) zones. You will frequently work in
these areas, which require proper gowning or double gowning attire to maintain safety and
quality standards.
Qualifications:
• Bachelor’s degree in engineering, Computer Science, Information Systems, or a related field (or equivalent experience).
• 3-5 years of experience supporting OT, manufacturing systems, or regulated enterprise systems in biotech, pharma, or CDMO environments.
• Hands-on experience with system administration, access control, and role management.
• Strong understanding of GMP environments, data integrity principles, and regulated operations.
• Ability to troubleshoot complex systems and work across technical and non-technical teams.
Preferred
• Experience supporting manufacturing execution systems (MES), laboratory systems (LIMS), or other GxP platforms.
• Experience building internal tools, dashboards, or low-code/no-code business applications.
• Familiarity with system validation, change control, and audit support.
• Experience working in fast-paced, growing organizations
• Participate in audits, inspections, and internal reviews as needed.
• Manage purchasing, inventory, and distribution for OT supplies, consumables, and equipment.
• Provide training and guidance to users on OT systems and tools. Support creating work
Instructions including multimedia and infrastructure to train staff and other employees on
common tasks (navigating applications, configuring equipment)
• Work closely with the quality team to manage, write, or own IT-related CAPAs, SOPs, policies, MOCs, work instructions, and deviations.
• Perform periodic access and audit trail reviews for systems.
• Manage backup and disaster recovery procedures for OT systems, including periodic restore testing and documentation.
• Support regulatory inspections and audits by providing system documentation, audit trails, and technical explanations to auditors as needed.
• Other activities as assigned by manager
Working Conditions:
• This position is required to work in a lab/office setting. The role requires walking, standing,
stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 40
pounds independently.
• This is an on-site position, working standard business hours on site,5 days a week.
• This role requires availability for on-call support during weekends or off-hours to address critical OT issues.
• We have multiple work sites, most within a mile of each other. Reliable transportation (personal vehicle) is required to move between locations as needed. Occasional long-distance travel may be required (Under 20%).
• Our facility includes GMP (Good Manufacturing Practice) zones. You will frequently work in
these areas, which require proper gowning or double gowning attire to maintain safety and
quality standards.
Qualifications:
• Bachelor’s degree in engineering, Computer Science, Information Systems, or a related field (or equivalent experience).
• 3-5 years of experience supporting OT, manufacturing systems, or regulated enterprise systems in biotech, pharma, or CDMO environments.
• Hands-on experience with system administration, access control, and role management.
• Strong understanding of GMP environments, data integrity principles, and regulated operations.
• Ability to troubleshoot complex systems and work across technical and non-technical teams.
Preferred
• Experience supporting manufacturing execution systems (MES), laboratory systems (LIMS), or other GxP platforms.
• Experience building internal tools, dashboards, or low-code/no-code business applications.
• Familiarity with system validation, change control, and audit support.
• Experience working in fast-paced, growing organizations
Compensation Range: The base compensation range for this role is between $100,000 and $120,000. However, the actual compensation may vary depending on your experience and qualifications.
Health Benefits and Program: Bionova offers health benefits at a subsidized rate.
Healthcare, Dental, and Vision insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 days of Holidays and 5 days of Sick Leave.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.