Manager of Facility Services
Reports to Director of Manufacturing
Full time. Weekends or weeknight work occasionally required depending on production schedule or process needs.
The Manager of Facility Services is responsible for the development and oversight of various facets of the facility including utilities (RO water, vacuum, clean gasses, backup generator, HVAC), pest control, waste removal, manufacturing safety, and ensuring custodial staff and external contractors meet quality expectations in timeliness, performance, and cost. The successful candidate will also develop and oversee, with Quality Assurance, a calibration, preventative maintenance, and qualification program for all facility, manufacturing and quality equipment and tools.
Duties and Responsibilities include:
- Oversight of all site RO (reverse osmosis) operations and systems.
- Oversight of all site plant waste neutralization and removal.
- Manages all outsourcing for plant maintenance and utilities functions.
- Oversight of all autoclave operations and maintenance.
- Manages and develops direct reports that may include but not limited to Associate Managers, Supervisors and team leads.
- Acts as area manager in compliance and utility related investigations and provides insight.
- Participates as Subject Matter Expert for utilities functions during regulatory inspections.
- Develops and updates SOPs related to new and existing systems.
- Plans annual utilities operations budget and develops/negotiates contracts with service providers.
- Responsible for all aspects of planning and executing utilities related projects, in consideration of GMP regulatory compliance and EH&S expectations.
- Maintains utilities work records.
- Develops and implements continuous improvement ideas and suggestions for the site and utility systems.
- Owns and executes corrective and preventative actions (CAPAs).
- Assists with estimates for new facility construction costs.
- Plans and schedules modifications to all facilities systems.
- Manages projects for installations, expansion, and relocations of services and personnel.
- Interface regularly with Quality Assurance, Manufacturing and other functional areas in order to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables.
- Continually reassess Facilities systems and processes for adherence to cGMPs and industry best practices and implement changes/improvements as needed.
A bachelor’s degree in a life science related field, engineering discipline, or related field and a minimum of 5+ years of cleanroom facilities operations and 2+ years leadership or project management experience preferred, including experience with increasing responsibilities in complex facilities performing research or manufacturing of biological process.
Experience and Skill Requirements
Experience in the pharmaceutical and/or biopharmaceutical facility management and utilities, engineering, maintenance, computerized systems and validation activities in a GMP environment is preferred but not required.
Exceptional human relations, personnel management and communication (written, verbal, and listening) skills are required. Organizational project management skills are essential, along with analytical and critical thinking abilities. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment. Must have the ability to lead, motivate and influence others. Compliance issues may create difficult situations for the individuals involved; therefore, objectivity and professionalism are essential.
Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment in ambiguous situations while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities. Must be self-motivated and able to independently schedule workday activities with minimal direction.