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Director, Engineering & Maintenance

BioSpace, irvine, ca, United States


We are seeking a Director of Engineering & Maintenance to lead critical site functions, drive strategic initiatives, and elevate operational excellence across our pharmaceutical manufacturing operations.

This is a leadership role where technical expertise meets strategic vision. As a key member of the Site Leadership Team (SLT), you will play a pivotal role in shaping the future of our site through engineering innovation, capital project execution, and people development.

As Director Of Engineering & Maintenance, You Will

  • Define and execute the mid- and long-term engineering strategy aligned with site and corporate goals
  • Lead major CAPEX projects from concept through execution—ensuring delivery on time, within budget, and to specification
  • Establish and drive robust governance processes to track and improve operational performance
  • Oversee Engineering, Maintenance, Facilities, Automation, and Calibration teams
  • Ensure equipment reliability, asset lifecycle optimization, and KPI performance
  • Partner cross-functionally with Manufacturing, M&ST, Quality Assurance, and Project Management
  • Support facility expansions, equipment acquisitions, and site modifications, including qualification activities
  • Drive continuous improvement in aseptic operations, clean utilities, and GMP compliance
  • Lead technical evaluations, equipment selection, and implementation of advanced manufacturing technologies
  • Actively contribute to Deviation, CAPA, and Change Control (DCR) processes
  • Manage departmental budgets, including CAPEX and maintenance budgets exceeding $3M
  • Develop and mentor a high-performing engineering organization

What You Bring

  • Strong leadership presence with the ability to inspire, develop, and lead technical teams
  • Deep expertise across:
    • Pharmaceutical engineering & manufacturing
    • Maintenance & reliability systems
    • Automation & process equipment GMP compliance and aseptic operations
  • Proven ability to manage complex capital projects and cross-functional initiatives
  • Excellent communication skills with the ability to influence at all levels
  • Strong analytical mindset with sound decision-making capabilities
  • Proficiency with tools such as AutoCAD, SolidWorks, Microsoft Project, Excel, and related systems

Required Experience & Education

  • Bachelor’s Degree in Engineering (or equivalent)
  • 15+ years of engineering experience in the pharmaceutical industry
  • 7+ years leading engineering, maintenance, and facilities teams
  • 5+ years of GMP experience, including aseptic processes and clean utilities
  • Demonstrated ownership of CAPEX and maintenance budgets > $3M

Why Siegfried?

We offer a comprehensive and competitive benefits package designed to support your health, wealth, and work-life balance:

  • Medical, dental, and vision coverage (including dependents)
  • Life insurance, short- and long-term disability
  • Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
  • 401(k) with company match
  • Generous Paid Time Off (PTO)
  • Target Base Salary: $200,000 – $280,000

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related factors.

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