Bionova Scientific · 14 hours ago
Operational Technology Engineer/Sr. Engineer
Fremont, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $120K/yr
3+ years expBionova Scientific is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products. The Operational Technology Engineer is responsible for maintaining and improving Bionova’s OT environment while ensuring compliance with GMP standards and supporting various functions within the organization.
BiotechnologyPharmaceuticalBiopharma
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
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
Bionova Scientific
Bionova Scientific is a biologics company presents services for cell line development.
51-200 employees
H1B Sponsorship
Bionova Scientific 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 (7)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Great Point Partners
2022-04-19Acquired
2019-06-03Private Equity
Leadership Team
Darren Head
Chief Executive Officer
Rod Fuhriman, CPA, MBA
Chief Financial Officer
Recent News
Genetic Engineering News
2026-02-06
Genetic Engineering News
2026-01-11
Company data provided by crunchbase