Process Maintenance Manager

GSK

About The Position

At GSK Rockville, we are looking for a Facilities Manager who will be responsible for providing support site wide for utility systems, routine and preventative maintenance and repairs for all equipment/systems. You will supervise a staff of maintenance and custodial personnel to provide maintenance requirements and supervise the scheduling and coordinating of maintenance contract work for all building related equipment and systems. This individual will coordinate activities with other Operations groups (Manufacturing, Engineering, EHS, Validation, Materials Management, and Quality Systems) to create and implement policies and to provide appropriate resources to support process activities and production schedules site wide. In this role, the Facilities Manager supervises all activities associated with annual shutdown activities. Individual provides updates and detailed reports to the Senior Facilities Manager as required. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Supervise Facilities related activities for GSK’ pre-clinical, clinical and commercial cGMP activities. Assume site-wide Facilities Maintenance responsibilities. Structure organization to perform functions required to maintain and repair GSK facilities systems and equipment in a cost-effective manner. Actively recruit obtain and structure a Facilities Maintenance staff that is second to none. Develop in-house expertise for critical process maintenance and operations functions. Prepare and implement recommendations for making the Facilities Maintenance SOP’s and other related documentation uniform and consistent. Implement and maintain a state of the art computerized maintenance management system (Enterprise Asset Management System) to schedule, track and document all preventative maintenance and repair activities site-wide. Exhibit an ability to work with other Operations groups (Manufacturing, Engineering, Validation, Materials Management, and Quality Systems) to create and implement policies and to provide appropriate resources to support process activities and production schedules at all areas of operations. Ensures Self Inspection Universe procedures for area of responsibility are in place and in use. Ensure all Environmental, Health, & Safety (EHS) adverse event investigations are started within 24 hours Ensure all EHS adverse event Root Cause Analysis (RCAs) are documented and completed within 5 days Own the EHS risk assessment process within management area (i.e., identify operations needing to be assessed, approve completed assessments, and ensure any required mitigation/Corrective and Preventative Actions (CAPAs) are implemented on time At least weekly, review Zero Accident Promotions (ZAPs) submitted by team, identify trends and any applicable CAPAs, and discuss with team At least weekly, conduct routine EHS-focused process confirmation at in the area of management At least monthly, review area self-inspection reports to identify recurring EHS issues and ensure effective CAPAs are implemented

Requirements

Bachelor’s degree
Experience within clean room environment in a maintenance aspect
Experience managing facilities maintenance program
5+ years' experience with a biopharmaceutical company.

Nice To Haves

Graduate degree or Advanced degree
Production experience is a plus
Familiar with FDA and cGMP requirements and implementing and maintaining procedures to meet such guidelines.
Strong organizational skills are a must.
Leadership experience should include direction with building design requirements, staffing organization, as well as licensing and clinical operating procedures.
Stationary Engineers License State of Maryland (Preferred)
EPA Certified Universal Refrigerant License (Preferred)
State of Maryland Board of Waterworks & Waste Systems Operators License (Preferred)
State of Maryland Board of Waterworks & Waste Systems Superintendents License (Preferred)

Responsibilities

Supervise Facilities related activities for GSK’ pre-clinical, clinical and commercial cGMP activities.
Assume site-wide Facilities Maintenance responsibilities.
Structure organization to perform functions required to maintain and repair GSK facilities systems and equipment in a cost-effective manner.
Actively recruit obtain and structure a Facilities Maintenance staff that is second to none.
Develop in-house expertise for critical process maintenance and operations functions.
Prepare and implement recommendations for making the Facilities Maintenance SOP’s and other related documentation uniform and consistent.
Implement and maintain a state of the art computerized maintenance management system (Enterprise Asset Management System) to schedule, track and document all preventative maintenance and repair activities site-wide.
Exhibit an ability to work with other Operations groups (Manufacturing, Engineering, Validation, Materials Management, and Quality Systems) to create and implement policies and to provide appropriate resources to support process activities and production schedules at all areas of operations.
Ensures Self Inspection Universe procedures for area of responsibility are in place and in use.
Ensure all Environmental, Health, & Safety (EHS) adverse event investigations are started within 24 hours
Ensure all EHS adverse event Root Cause Analysis (RCAs) are documented and completed within 5 days
Own the EHS risk assessment process within management area (i.e., identify operations needing to be assessed, approve completed assessments, and ensure any required mitigation/Corrective and Preventative Actions (CAPAs) are implemented on time
At least weekly, review Zero Accident Promotions (ZAPs) submitted by team, identify trends and any applicable CAPAs, and discuss with team
At least weekly, conduct routine EHS-focused process confirmation at in the area of management
At least monthly, review area self-inspection reports to identify recurring EHS issues and ensure effective CAPAs are implemented