Facilities Operations Manager II
GENERAL SUMMARY OF POSITION:
The Facilities Operations Manager II is responsible for managing the operations and maintenance group across multiple sites to ensure that the equipment is operated and maintained in compliance with current Good Manufacturing Practices (cGMP)/current Good Laboratory Practices (cGLP) and industry standards. Performs both hands-on operation and maintenance and supervisory functions. The individual is responsible for delivering FDA compliance and excellent customer service in a 24-hour manufacturing environment within a prescribed budget. This is a performance based position where success is measured through the achievement of organizational and departmental goals.Responsibilities
- Manages operations and maintenance program for FDA licensed manufacturing facility and associated research and development operations. This includes:
- Operation, maintenance, troubleshooting and repair of cGMP manufacturing and support equipment.
- Development of routine operating and maintenance methods.
- Establishment of preventive maintenance schedules and tasks.
- Generation, review and revision of operating and maintenance SOPs.
- Scheduling and documentation of maintenance and repair activities through a computerized maintenance management system (CMMS).
- Managing the daily schedule according to the priority of requests, operating conditions, and the availability or manpower and materials.
- Ensures standardization of maintenance and operation procedures across multiple sites.
- Develops and maintains management metrics for operations and maintenance programs.
- Specifies and procures operations and maintenance related tools, standards, instruments and equipment
- Adheres to budgets, schedules and performance requirements.
- Negotiates and manages multiple contracts with outside vendors performing operations and maintenance on various types of equipment.
- Maintains maintenance and operations records, equipment identification and tagging.
- Writes and implements change controls to maintain cGMP compliance.
- Writes incident/deviation reports as necessary, performing root cause analyses and identifying corrective actions as appropriate.
- Manages employee performance and provide coaching and mentoring of direct reports.
- Serves as technical advisor on equipment issues.
- Ensures successful completion of work orders for maintenance of equipment and building systems..
- Performs additional job related duties as required.
- Requires a Bachelors degree preferably in an engineering discipline or equivalent with a minimum of 5 years of relevant experience, including management experience in chemical or biotech/pharmaceutical industries. Mechanical or chemical engineering degree preferred
- Prior industry working experience in a cGMP environment within a biotech or pharmaceutical company preferred
- Proven supervisory capability
- Excellent written and verbal communication skills
- Excellent customer service skills
- Experience in any of the following areas preferred:
- Managing/supervising union personnel
- Managing contractors
- May require frequent travel between the JP and Mattapan campuses
- Ability to ensure 24-hour operations which may dictate irregular work schedules based on business needs
- Ability to lift fifty (50) pounds