Asahi Kasei Bioprocess America, Inc. · 20 hours ago
Operational Technology Engineer/Sr. Engineer
Fremont, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $120K/yr
3+ years expAsahi Kasei Bioprocess America, Inc. is focused on developing and manufacturing recombinant protein products. The Operational Technology Engineer/Sr. Engineer will assist with SOP development, manage OT supplies, and provide training on OT systems while ensuring compliance with regulatory standards.
BiotechnologyManufacturing
Responsibilities
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
Qualification
Required
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
Benefits
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.
Company
Asahi Kasei Bioprocess America, Inc.
As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust, by dependably supplying innovative yet exceptionally reliable bioprocess consumables, equipment and scientific support services.
51-200 employees
H1B Sponsorship
Asahi Kasei Bioprocess America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Adam B.
VP of Finance/CFO
Lena Liu
Strategic Partnership Senior Manager
Recent News
GlobeNewswire News Room
2025-02-25
2025-02-18
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