Operational Technology Engineer/Sr. Engineer

Asahi Kasei•Fremont, CA

1d•$100,000 - $120,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

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