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Senior Engineer, OT

BioTalent

  • Tustin, CA
  • Today
  • $93,000–$116,000 Per Year
  • Full-time

Highlights

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

Numbers & Facts

LocationTustin, CA
Job TypeFull-time
Salary$93,000–$116,000 Per Year
Company Size11 - 50
HeadquartersNew York, NY, US

Description

Senior Engineer, OT | Tustin, CA

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

 

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.

Job Responsibilities

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.

Qualifications

Experience with a combination of platforms such as:

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

 

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.

Preferred

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.

Benefits

401K Match, Medical, Dental, Vision

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