Director of Engineering

Eleven Executive Search has been retained by a rapidly growing pharmaceutical company as they're seeking a newly created role leading as Director of Engineering in Northern California.

The Director of Engineering will serve as the senior engineering leader for the manufacturing site, providing strategic and operational leadership across engineering, automation, process engineering, capital projects, reliability, and maintenance. This role is critical to the company’s next phase of growth. The successful candidate will partner closely with manufacturing leadership to evaluate future demand scenarios, develop capacity expansion strategies, guide capital investment decisions, and ensure the site is prepared to support significant commercial scale-up.

This leader will be responsible for building and developing the engineering and maintenance organization while establishing the systems, processes, and technical roadmap required to support a modern aseptic manufacturing operation.

What you’ll bring:

Strategic Engineering Leadership

• Develop and execute the site’s long-term engineering, capacity, and infrastructure strategy.
• Partner with Manufacturing, Technical Operations, and Executive Leadership to translate commercial forecasts into facility and production capacity plans.
• Evaluate current and future manufacturing capabilities, identifying bottlenecks, constraints, and investment opportunities.
• Serve as a key technical advisor on facility expansion, capacity modeling, and network growth initiatives.
• Develop business cases and investment roadmaps for future capital projects.

Capacity Expansion & Commercialization

• Lead engineering support for major site expansion initiatives, including additional manufacturing space and future sterile filling capacity.
• Define equipment, utility, facility, and infrastructure requirements needed to support future product launches and commercial growth.
• Evaluate expansion scenarios involving formulation, filling, isolator technology, clean utilities, and supporting infrastructure.
• Partner with external engineering firms and internal stakeholders to challenge assumptions, validate models, and ensure scalability.

Engineering & Maintenance Excellence

• Build and lead a high-performing engineering and maintenance organization.
• Establish predictive and preventive maintenance programs from the ground up.
• Implement reliability-centered maintenance practices and asset management strategies.
• Develop KPIs, performance metrics, and continuous improvement programs.
• Create sustainable systems for equipment lifecycle management, spare parts planning, and technical documentation.

Capital Projects & Technical Operations

• Lead equipment selection, procurement, installation, commissioning, qualification, and startup activities.
• Oversee capital project execution from concept through implementation.
• Ensure engineering activities comply with cGMP, FDA, and regulatory requirements.
• Drive automation, controls, and process optimization initiatives.
• Support technology transfer, validation, and commercialization activities

Leadership & Talent Development

• Recruit, develop, and mentor engineering and maintenance talent.
• Build organizational capabilities to support future growth.
• Foster a culture of accountability, innovation, and technical excellence.
• Collaborate cross-functionally with Manufacturing, Quality, Validation, Supply Chain, and Technical Services.

Ideal Candidate Profile:

The ideal candidate combines strategic vision with hands‑on execution and has successfully helped scale pharmaceutical manufacturing organizations through periods of rapid growth.

Required Experience

• Bachelor’s degree in Engineering or related technical discipline.
• 10+ years of progressive engineering leadership experience within pharmaceutical, biotech, CDMO, or sterile manufacturing environments.
• Experience leading engineering organizations supporting aseptic manufacturing operations.
• Demonstrated success leading facility expansions, capacity growth initiatives, and major capital projects.
• Experience building engineering, reliability, and maintenance programs in growing organizations.
• Strong understanding of process engineering, automation, controls, and manufacturing equipment systems.
• Experience supporting FDA-regulated manufacturing environments.

Preferred Experience

• Sterile or aseptic fill/finish mfg. experience
• Experience with two or more of the following:
• Vial filling
• Prefilled syringe manufacturing
• Experience with isolator technology and aseptic processing.
• Experience supporting commercialization, scale-up, and new product introductions.
• Experience with utility systems supporting sterile manufacturing operations.