Senior Director, Facilities and Engineering
The Senior Director of Facilities and Engineering will lead the strategic and operational oversight of all physical infrastructure, engineering systems, and facility operations across our biotech manufacturing site. This role is critical in ensuring that our facilities support innovation, meet stringent regulatory requirements, and scale effectively to accommodate growth. The ideal candidate brings deep technical expertise, leadership experience in a regulated biotech or pharmaceutical environment, and a proactive approach to operational excellence and compliance.
Responsibilities
Strategic Leadership & Planning
- Develop and execute long-term facilities and engineering strategies aligned with the company's scientific, manufacturing, and commercial goals.
- Partner with executive leadership to plan site expansions, infrastructure upgrades, and capital projects.
- Lead site master planning to ensure facilities are optimized for current and future needs, including GMP and R&D environments.
Facilities & Engineering Operations
- Oversee daily operations and maintenance of building systems, cleanrooms, labs, utilities (HVAC, water systems, compressed air, etc.), and critical infrastructure.
- Ensure all facilities meet operational readiness and regulatory compliance (FDA, EMA, OSHA, EPA, etc.).
- Direct cross-functional projects related to facility optimization, sustainability, and energy efficiency.
- Assessment of current state and implementation of new best practices.
Capital Projects & Construction
- Lead all aspects of facilities-related capital projects from concept through completion, including design, construction, commissioning, and qualification.
- Manage project timelines, budgets, and external contractors and vendors to ensure quality and compliance.
Regulatory Compliance & Safety
- Maintain strict adherence to cGMP, GLP, and EH&S standards.
- Collaborate with Quality, EHS, and Regulatory Affairs to ensure compliance with local, state, and federal regulations.
- Implement and oversee facility validation, calibration, and maintenance programs in support of GxP operations.
Leadership & Team Development
- Lead and develop a multidisciplinary team of engineers, facility managers, technicians, and support staff.
- Foster a culture of continuous improvement, reliability, and proactive problem solving.
- Drive training, succession planning, and professional development within the department.
Qualifications
Required:
- Bachelor’s degree in Engineering, Facilities Management, or a related technical field.
- Minimum of 15 years of experience in facilities and engineering roles, with at least 10 years in senior leadership within the biotech, pharmaceutical, or life sciences industry.
- Strong knowledge of building systems, GMP facilities, lab environments, and validated systems.
- Proven track record managing large-scale capital projects and multidisciplinary teams.
- Familiarity with FDA, EMA, OSHA, and other regulatory agency requirements.
Preferred:
- Master’s degree in Engineering, Business, or related discipline.
- Professional certifications such as PMP, LEED AP, or CFM.
- Experience supporting both R&D and GMP manufacturing facilities.
Working Conditions:
- On-site presence required.
- Availability for after-hours response in case of facility emergencies or critical system failures
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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