Director, Facilities and Engineering
The Director of Facilities and Maintenance is responsible for managing all facilities services and non-GMP / GMP Site Services at our client’s manufacturing site. The position will direct the development of departmental workflows, workload management, guidance instructions or procedures and general technical support to cross-functional manufacturing, lab, operations, and office staff and is as such critical to ongoing operations.
The site consists of office space, laboratory facilities, central utilities, warehouses, drug product filling, manufacturing, and all support infrastructure and equipment.
This function will plan and coordinate daily operations to meet preventive maintenance schedules, strategies of all utilities and process equipment in full compliance with Quality, Safety, and cGMP standards. This includes the management and leadership of direct staff and outsourced partnerships with contract firms.
- Provides leadership and supervision Maintenance and Engineering department in support of Manufacturing operations and Facility Services. Creates goals and tracks metrics against operational goals. Aligns priorities across functional subgroups in strong collaboration with global functions and site leadership team.
- Develops, communicates, and implements tactical goals in support of Manufacturing operations and Facility utilization.
- Responsible for coaching and professional development of direct reports and staff
- Leads from a strategic and operational perspective external service providers for site services, project work and GMP and non-GMP maintenance and manufacturing support incl. contract management.
- Oversees the development, implementation and execution of Facilities and Engineering strategy.
- Establishes procedures and programs to ensure safe, compliant, and reliable operations including business continuity and cGMP compliance.
- Represents the site on audits and inspections by regulatory agencies.
- Ensures and maintains strong safety record across department and strategic contract partners.
- Successfully teams with site leadership teams, manufacturing, quality, and human resources to achieve defined objectives.
- Supports capital projects as necessary.
- Develops forecasts and plans of department/business group requirements for facilities and engineering management and capital expenses.
- Identifies and prepares capital requests for facilities related projects in conjunction with Capital Planning and PM. Provides budget oversight and ensures sufficient resource allocation.
- Provides leadership and mentoring / development to engineering team
- You are a passionate leader and developer of diverse, high performing teams. You have the management skills to set priorities, manage through roadblocks, and appropriately communicate escalations. You also love identifying and implementing system and process improvements.
- A minimum of 10 years of facility and maintenance experience in a cGMP environment. 12-15+ years of facility and maintenance experience a cGMP environment preferred
- Bachelor’s Degree in an Engineering or related field.
- Practical knowledge and application of cGMP and FDA, EMA regulations.
- Experience in developing facilities and engineering management programs for a major site.
- Demonstrated management and track record in safety.
- Experience coaching, developing, and managing a staff of professional employees as well as contractors.
- Experience managing and negotiating with contracting facilities services for manufacturing and commercial setting highly desired
- Preferred Expertise in implementing lean six sigma, continuous improvements, and best practices culture