POSITION SUMMARY

This position is responsible for Supervision and operating and maintaining the general and critical utilities equipment at the site, as well as perform the necessary maintenance to ensure the equipment operates as expected and mitigate the risk of unplanned down time. The candidate will work on mechanical, electrical, electronic, pneumatic, and hydraulic components and systems. Under general supervision and/or independently identifies, prevents and solves technical problems related to assigned equipment and area.

The candidate will complete preventive maintenance, repairs, and routine sanitization and passivation for the Monroe critical utility systems in accordance with company standard operating procedures, equipment manuals, and current industry regulations and practices in the U.S.A. and the state of North Carolina. Must be familiar with gas fired boilers, HVAC (chillers, air handler units, hot water systems), purified water systems, water for injection, pure steam, compressed air systems, Air handler units ,and nitrogen systems. Initiates, coordinates, and completes the required change control process for critical utility systems. Coordinates, tracks, and develops utility technicians and contractors working in the group.

The candidate will also own and process all Quality Management System Items such as Corrective-Preventive Actions (CAPA), Quality Events (QE), Change Controls and Action Items assigned to him.

OVERALL JOB RESPONSIBILITIES

Responsibilities

Results Expected/ Target

Complete Training

All training stays up to date with no past due.

Complete Corrective Work Orders

Work orders completed and properly documented in the CMMS with proper attachments.

Complete PM Work Orders

Preventative work orders completed and properly documented in the CMMS with proper attachments.

Clean & Organize Shop Areas

Maintain Clean work, shop and office areas. 5S toolboxes and cabinets.

Order Parts

Identify parts needed using manuals or contacting vendors for part numbers and request quotes from vendors.

Update PM’s and SOP’s

Make PM’s and SOP’s more effective by adding requirements that are missing and removing unnecessary steps

Update Drawings

Identify and redline drawings and submit changes to be implemented as required per Change Controls.

Complete QMS Items

Own and process all Quality Management System Items such as Corrective-Preventive Actions (CAPA), Quality Events (QE), Change Controls and Action Items

Mentor and Train other Mechanics

Teach other mechanics how to use new technology for troubleshooting fabricating and installation.

KNOWLEDGE, SKILLS AND ABILITIES

Education (degree / diploma)

Bachelor Degree or higher and Bio or Pharma certificate (experience may be considered in lieu of degree or certificate).

Experience

Minimum of five (5) year’s recent and relevant experience as a utility technician, boiler/Physical Plant Operator or team leader in pharmaceutical or hospital environments.

Knowledge and Skills (Functional / Technical)

• Proficient and functional speech and written fluency with English language.
• Knowledge and skill in maintenance of assembly, set-up, dis-assembly, cleaning, troubleshooting, maintenance, and repairs on pharmaceutical utility equipment and mechanical, electrical, electronic, pneumatic, and hydraulic components and systems.
• Oversee the day-to-day operations of the utilities department.
• Evaluates systems and/or facilities to determine maintenance or repairs that need to be performed.
• Assesses building systems to plan work assignments and project schedules.
• Develop maintenance procedures and schedules.
• Ensures correct, accurate and timely documentation of work performed as per FDA requirements.
• SOP preparation for maintenance, cleaning and operation of Utility equipment.
• Familiar with Computerized Maintenance Management Software (CMMS) such as BMRAM/SAP for electronic PM documentation.
• Basic knowledge of Pharma documents for SOP, change control, Incident & CAPA.
• Communicate assignments and major tasks to employees. Make sure they have all the instructions necessary to complete assignment properly.
• Periodically check the work progress of each maintenance employee. Provide immediate assistance and instruction as needed.
• Assists with budget estimates and costs of specific repair projects.
• Initiates, conducts, and records assembly, set-up, dis-assembly, cleaning, troubleshooting, maintenance, and repairs on utility and clean system equipment and mechanical, electrical, electronic, pneumatic, and hydraulic components associated with that equipment.
• Takes ownership for operational and maintenance status of utility and clean system equipment.
• Hires and trains maintenance department staff.
• Organizes and oversees the schedules and work of maintenance staff.
• Conducts performance and disciplinary actions that are timely and constructive.
• Basic knowledge on Building management system operation.
• Performs other related duties as assigned.

Leadership / Managerial Attributes

Minimal supervision with considerable latitude for independent judgment. Completes difficult assignments without assistance. May mentor less-experienced team members and assist team lead.

Leadership / Managerial Attributes

Minimal supervision with considerable latitude for independent judgment. Completes difficult assignments without assistance. May mentor less-experienced team members and assist team lead.

Other requirements (licenses, certifications, specialized training)

Bio or Pharma certificate, electrical license, Boiler or HVAC certified, PLC certification, or calibration certification.