
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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