Supervisor, Facilities Maintenance

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The Facilities Supervisor is the key liaison to the facilities department to ensure that installed systems meet all applicable codes and standards, support cGMP manufacturing operations and are maintained in accordance with a well-established preventative maintenance program. The Facilities Supervisor's primary responsibilities are to support facilities management in planning, maintaining, scheduling, implementing best practices, improving and promoting safety for the Facilities, Systems, Utilities and Equipment (FSUE). The incumbent supervises the GMP maintenance staff and will be responsible for execution of the day-to-day maintenance to maintain (FSUE) in an operational state compliant with regulatory requirements for a GMP environment. Responsible for driving the PCI culture through values inclusive of customer service standards. Accountable for outstanding customer service to all external and internal functional teams.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Promote safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
• Responsible for supervision of maintenance and Facilities activities for 24/7 GMP operations.
• Establish all required preventive maintenance plans

utilizing the Regulatory Asset Manager (RAM) System.

• Ensure preventive maintenance work plans are current, accurate, written with sufficient detail, and executed
• Provide long term solutions and day-to-day support to all operating teams having issues with troubleshooting, problem analysis, equipment failures, etc.
• Generate, revise and review cGMP documentation to ensure compliance to all applicable governing bodies.
• Support Quality Incident Investigations, CAPAs and ensure completion of assigned CAPAs completely on time.
• In collaboration with Facility Manager, ensure technicians are adequately trained on site facility and systems
• Schedule and coordinate shutdowns to include preventative maintenance, projects, and facility modifications.
• In collaboration with Facilities Manager, prioritize and plan work activities for maintenance technicians; use time efficiently; develop realistic action plans. Work closely with other cross functional support groups
• Supervise assets and spare part usage for manufacturing equipment and make changes to improve cost and efficiency.
• Support the implementation and supervision of predictive, corrective and preventive maintenance to meet GMPs.
• Organize, review, prioritize, and schedule daily Maintenance Work Orders (MWO) and Preventative Maintenance (PM) work. Efficiently coordinate the workflow and documentation of PMs and WOs.
• Monitor and report equipment performance and efficiency data and identify any trending. Using data analysis, troubleshoot and determine root cause of equipment failures and develop solutions to prevent future failures.
• Drive proper cGMP documentation practices and data quality. Utilizes system to manage internal and external resources according to established workflows.
• Ensure that all areas and equipment are maintained in Good Housekeeping condition and facilities are always in inspection/audit ready states.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL REQUIREMENTS

• Frequent standing, walking, bending, kneeling, squatting, and reaching
• Able to lift up to 50 lbs.
• The employee must occasionally lift and/or move up to 50 pounds

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

• Engage, motivate and positively influence others in the pursuit of achieving PCI goals and objectives.
• Participates in interviewing, hiring and issuing disciplinary actions to employees as required with accurate tracking and documentation. Conducts annual employee reviews in a fair, timely manner

TRAVEL < 10% or >20%)

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to work in a face paced environment
• Resilient through operational change
• Able to work in a highly complex environment with competing demands and priorities
• Ability to work varied hours as required by the production schedule

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION

• AS/BS degree or equivalent experience and Proven 3 years' experience in a GMP Facility in a technical role.

EXPERIENCE

• Extensive knowledge of utility and facility equipment such as HVAC air handlers, refrigeration, cold rooms, freeze dryers, steam, chillers, cooling tower, pumps & drives, WFI, RODI, Fill finish equipment, waste and emergency generators.
• Have working knowledge of hazardous chemicals and their disposal, OSHA, EPA, and FDA requirements.
• Requires in-depth knowledge of cGMPs as they relate to facilities maintenance to ensure processes and facilities are compliant and changes are consistent with necessary controls. Experience with Microsoft Office Suite, RAM,
• Demonstrated skills in leadership, communication, teamwork, and change management.

PROFESSIONAL SKILLS

• Help to promote a maintenance culture which embraces reliability-centered maintenance tools to drive continuous improvement with the maintenance team. This includes highly effective maintenance planning, execution, spare parts, and improvement in equipment reliability.
• Provide excellent customer service and create strong partnerships with internal and external partners including Quality Assurance, Material Management, Quality Control, Manufacturing, Engineering, EH&S, Finance, and IT
• Excellent written and verbal communications skills.
• Strong organizational skills and the ability to meet deadlines with minimal supervision.
• Read electrical schematics and single line diagrams. Must be able to work in a clean room/ISO environment.
• Demonstrated skills in leadership, communication, teamwork, and change management.

QUALITIES

• Possess strong attention to detail
• Team oriented with the demonstrated capacity to lead and mentor others
• Results driven individual who models this trait for the team
• Calm under pressure and able to think clearly to link day to day work to business objectives
• Highly collaborative and has ease in engaging cross functional teams to solve challenges

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.