Manages Maintenance department assuring production equipment and facility readiness of production environment to support Right First Time and On Time Delivery performance of the site. Maintains cleanliness of facility, conforming to defined cGMP, Safety and Environmental safety regulations.
- Manages the maintenance of plant, property and manufacturing & facility equipment. Directly supervises the Maintenance Coordinator, Storekeeper, Security and Supervisory positions. Develops, and continuously improves, preventative maintenance methods for existing and new equipment. Provides troubleshooting leadership and technical support for operation issues that may be related to equipment, facilities or utilities. Be on call for major maintenance problems. Approves and issues all calibration procedures and monitors status of all preventative maintenance and calibration work orders to ensure completion and adherence to compliance requirements. Represents Maintenance KPIs on weekly basis. Generates weekly reports for the Senior Director of Engineering.
- Supports Quality department by managing assigned DRs and CAPAs and assisting during regulatory audits. Maintains facility records and equipment to operate within validated guidelines.
- Maintains a safe working environment and ensures departmental EHS training, DRs and CAPAs are completed on time. Acts as Fire Chief. Monitors safe working practices. Continuously seeks energy saving opportunities.
- Determines manpower and training needs to coordinate maintenance activities. Selects, develops and evaluates staff to ensure the efficient operation of the maintenance function. Works with and advises staff on administrative policies and procedures, Participates in engineering project meetings. Leverages PMP to ensure department and site goals are achieved.
- Prepares and tracks maintenance budgets for departments under management control. Manages all external contracts for maintenance facility services (e.g. laundry, security, snow removal, utilities etc.). Oversees set-up of shop stores and maintenance of spare part inventory levels. Recommends capital equipment 5 year plan and prepares justifications to purchase.
- Minimum Bachelor of Science (B.Sc.) in Engineering or related discipline.
- Minimum 10 years in maintenance related activities within a pharmaceutical manufacturing environment.
- Sound knowledge of Utility systems (PW, CDA, DC, HVAC, APUs, Chillers/Loop, Boilers/Steam/Condensate, SCADA, BAS, Electrical, Back Up Generator, Plumbing, etc), Processing systems (FBDs, HSGs, RCs, Coaters, Presses etc.) and Life Safety Systems.
- Proven ability to coach and develop staff as well as the technical ability to coordinate departmental business activities.
- Strong interpersonal and communication skills.
- Proficiency with the English language.
- Proven problem solving skills.
- Must have good working knowledge of GMP.