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Director, Engineering & Maintenance

Job in Irvine, Orange County, California, 92713, USA
Listing for: BioSpace
Full Time position
Listed on 2026-01-15
Job specializations:
  • Engineering
    Electrical Engineering, Manufacturing Engineer, Engineering Design & Technologists, Operations Manager
Salary/Wage Range or Industry Benchmark: 200000 - 230000 USD Yearly USD 200000.00 230000.00 YEAR
Job Description & How to Apply Below

Director, Engineering & Maintenance

Bio Space is seeking a Director of Engineering and Maintenance with a comprehensive understanding of engineering, manufacturing, quality, automation, and maintenance in the pharmaceutical industry. The role is a member of the Site Lead Team and works closely with stakeholders on site initiatives, equipment acquisition, and CAPEX projects.

Responsibilities
  • Accomplishment of investment projects according to customer needs (time, cost, functionality). Interface with Project Management, manufacturing, M&ST, and Quality Assurance.
  • Meet agreed upon budget and ensure compliance goals are met.
  • Evaluate critical utilities requirements to support site activities.
  • Minimize asset life‑cycle costs.
  • Provide management leadership and oversight to engineers, maintenance, facilities, and automation teams.
  • Oversee Maintenance, Facilities and Calibration activities.
  • Lead major CAPEX processes or equipment projects as required.
  • Provide technical support to the manufacturing group as required.
  • Fulfill responsibilities as a member of the DCR, Deviation and CAPA team.
  • Oversee design and installation of production tooling and equipment.
  • Provide technical support for evaluating and resolving CAPAs.
  • Responsible for department budgeting, equipment purchases, and project planning.
  • Evaluate testing and manufacturing equipment to recommend purchases for use in manufacturing.
  • Ensure availability of competent, high‑performing people and manage the engineering talent pool; stay abreast of emerging technologies to support high‑volume, high‑yield, high‑value aseptic operations.
  • Other duties as assigned by the immediate supervisor.
Required Knowledge,

Skills and Abilities
  • Ability to function well in a team environment.
  • Extensive interfacing with equipment manufacturers and diverse vendors.
  • Excellent oral and written communication skills.
  • Strong cross‑functional interfacing.
  • Well‑rounded engineering and project management experience.
  • Superior analytical and computer skills.
  • Capable of using sound judgment to make and defend recommendations.
  • Proficiency in Windows, Word, Excel, AutoCAD 14, Solid Works, Microsoft Project, etc.
Required

Education and Experience
  • Bachelor of Science Degree in Engineering or equivalent.
  • 15 years of engineering experience in the pharmaceutical industry.
  • 7 or more years of experience managing an engineering team, maintenance, and facility management.
  • >5 years of GMP experience, including aseptic processes and clean utilities.
  • Demonstrated responsibility for Cap Ex and maintenance budgets exceeding $3M.

Target base salary $200,000 - $230,000

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