Senior Engineer, OT

BioTalent; Tustin (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

BioTalent in the United States is seeking an experienced OT / Automation / Systems Engineer to support enterprise systems, manufacturing equipment, and laboratory instrumentation within a highly regulated biopharmaceutical environment.

You will lead technical design, administration, and lifecycle management of regulated systems, while collaborating with Engineering, IT, Quality, Operations, and vendors to ensure compliant operations and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Computer Science, IT, Life Sciences or related field.
• 5–7+ years of relevant experience in systems engineering, systems administration, application support, or regulated equipment support.
• Experience in GMP-regulated manufacturing or laboratory environments.
• Knowledge of 21 CFR Part 11, GAMP 5, and ALCOA+ / data integrity.
• Experience leading projects and mentoring junior engineers.
• Strong troubleshooting, documentation, communication, and problem-solving skills.

Responsibilities

• Lead technical design, administration, support, and lifecycle management of regulated systems and equipment.
• Develop and maintain system specifications, technical procedures, work instructions, and documentation.
• Support system testing, upgrades, change controls, deviations, CAPAs, and troubleshooting.
• Lead complex technical investigations and coordinate with vendors to resolve system issues.
• Support system security, access controls, backup, recovery, and business continuity.
• Provide technical guidance and training to engineers, technical staff, Operations, and cross-functional teams.
• Lead projects and identify opportunities for technology and process improvements.
• Support reliable and compliant operation of manufacturing and laboratory systems.

Skills

Regulatory knowledge

Troubleshooting

Documentation

Project mentoring

Cross-functional collaboration

Vendor coordination

Communication

Problem solving

Education

Bachelor's degree in Engineering, Computer Science, IT, Life Sciences

Tools

Emerson DeltaV

DeltaV Mobile

Rockwell FactoryTalk

Cytiva UNICORN

Sartorius MFCS/BioBrain

Sartocheck

Empower 3

Veeam

Acronis

Agilent HPLC

SpectraMax

BioTek

Beckman

Endosafe

UV/Vis

Job description

Are you an experienced OT / Automation / Systems Engineer with a background in GMP-regulated manufacturing or laboratory environments?

Location: Tustin, CA

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Work Arrangement: Full-time, onsite

Serve as a technical expert supporting enterprise systems, manufacturing equipment, and laboratory instrumentation within a highly regulated biopharmaceutical environment.

This is an opportunity to work on critical systems that support manufacturing, process development, and quality control operations while partnering with Engineering, IT, Quality, Operations, vendors, and cross-functional teams.

What You'll Do

• Lead technical design, administration, support, and lifecycle management of regulated systems and equipment.
• Develop and maintain system specifications, technical procedures, work instructions, and documentation.
• Support system testing, upgrades, change controls, deviations, CAPAs, and troubleshooting.
• Lead complex technical investigations and coordinate with vendors to resolve system issues.
• Support system security, access controls, backup, recovery, and business continuity.
• Provide technical guidance and training to engineers, technical staff, Operations, and cross-functional teams.
• Lead projects and identify opportunities for technology and process improvements.
• Support reliable and compliant operation of manufacturing and laboratory systems.

Experience with a combination of platforms such as:

Emerson DeltaV | DeltaV Mobile | Rockwell FactoryTalk | Cytiva UNICORN | Sartorius MFCS/BioBrain | Sartocheck | Empower 3

Equivalent regulated manufacturing or laboratory systems experience will also be considered.

What We're Looking For

• Bachelor's degree in Engineering, Computer Science, IT, Life Sciences, or related field; relevant experience may substitute.
• 5–7+ years of relevant experience in systems engineering, systems administration, application support, technical documentation, or regulated equipment support.
• Experience working in a GMP-regulated manufacturing or laboratory environment.
• Knowledge of 21 CFR Part 11, GAMP 5, and ALCOA+ / data integrity.
• Experience leading projects and mentoring junior engineers.
• Strong troubleshooting, documentation, communication, and problem-solving skills.
• Ability to manage competing priorities and respond to production-impacting issues.
• Computer System Validation (CSV) experience, including IQ/OQ/PQ.
• Experience with laboratory instrumentation such as Agilent HPLC, SpectraMax, BioTek, Beckman, Endosafe, UV/Vis, or equivalent.
• Experience with Veeam, Acronis, or similar backup/recovery tools.
• Familiarity with OT cybersecurity frameworks such as NIST 800-82 or IEC 62443.
• Experience supporting client or regulatory audits.

Work Authorization:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time