About The Position

The Senior Bioprocess Equipment Engineer supports manufacturing in a non-GMP pilot plant in Thousand Oaks, California. The engineer is accountable for the reliability, performance, and lifecycle management of assigned process equipment, including bioreactors, chromatography skids, TFF/UF/DF systems, cleaning systems, and single-use and stainless-steel systems. The position provides day-to-day, onsite technical support to Operations, emphasizing troubleshooting, maintenance coordination, and data-driven decisions. The engineer guides technical decisions during equipment issues, process changes, and system improvements; the role does not involve directly operating equipment. The engineer also supports preventive maintenance strategy, asset management (for example, in Maximo), and the introduction of new equipment, including design, commissioning, startup, and integration. The position identifies opportunities to use digital tools and AI to improve troubleshooting, reliability, and workflow efficiency. Success requires independence, technical depth, a reliability mindset, and cross-functional collaboration in a fast-paced development environment. This is a contract consulting engagement of at least one year, with likely extensions and/or conversion to permanent employment. The role is 100% onsite, with a regular schedule of 8:00 a.m. to 5:00 p.m., potential overtime, and a rotating on-call schedule of approximately one week every six weeks. Occasional weekend or after-hours support may be needed during the assigned rotation.

Requirements

  • One of the following education and experience combinations: doctorate degree; master's degree and 2 years of experience; bachelor's degree and 4 years of experience; associate degree and 8 years of experience; or high school diploma or GED and 10 years of experience.
  • Relevant pharmaceutical manufacturing engineering experience may be considered in lieu of the stated experience requirements.
  • Ability to independently diagnose equipment issues, explain root causes, and describe how resolutions were verified.
  • Ability to take accountability for assigned equipment and drive maintenance and reliability improvements using data.
  • Effective communication and collaboration with Operations, Maintenance, and support teams.
  • Ability to meet the consistent onsite requirement and participate in the rotating on-call schedule.
  • Ability to discuss technical experience and resume details sufficiently.

Nice To Haves

  • Experience with Maximo or another computerized maintenance management system (CMMS).
  • Experience applying AI workflows or implementing AI-enabled tools to improve engineering or maintenance work.
  • Experience applying AI workflows or implementing AI-enabled solutions.

Responsibilities

  • Provide engineering support for pilot plant bioprocess equipment, including bioreactors, chromatography skids, TFF/UF/DF systems, cleaning systems, and single-use and stainless-steel equipment.
  • Troubleshoot equipment issues, lead or support root cause analysis, and implement solutions that improve performance and reliability.
  • Identify and mitigate equipment risks, including failure modes and obsolescence, and drive proactive improvements.
  • Apply engineering fundamentals in thermodynamics, fluid systems, piping, electrical systems, and process controls to assess and resolve issues.
  • Use equipment history and available system or process data, including trend analysis and statistical methods such as SPC, to guide maintenance planning and engineering decisions.
  • Support equipment design, commissioning, startup, and integration for new or modified systems.
  • Translate process and operational needs into engineering solutions and clear documentation.
  • Coordinate with Operations, Maintenance, Instrumentation, Facilities, and Process Development teams to resolve issues and deliver improvements.
  • Lead or support small engineering projects, managing priorities, execution, and cross-functional coordination.
  • Identify opportunities to use digital tools and AI to improve troubleshooting, reliability, and workflow efficiency.
  • Support preventive maintenance strategy and asset management.
  • Maintain a consistent onsite presence to support daily operations and participate in a rotating on-call schedule.
  • Work in a non-GMP pilot plant while following applicable standards, procedures, and documentation practices.
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