Process Maintenance Manager

Role Summary

Process Maintenance Manager at GSK Rockville. Responsible for providing site-wide support for utility systems, routine and preventative maintenance and repairs for all equipment and systems. Supervises maintenance and custodial staff and coordinates maintenance contract work for building equipment and systems, coordinating with Operations groups to support process activities and production schedules site-wide. Oversees annual shutdown activities and provides updates to the Senior Facilities Manager.

Responsibilities

• Supervise facilities-related activities for pre-clinical, clinical, and commercial cGMP activities.
• Manage site-wide facilities maintenance to maintain and repair facilities systems and equipment in a cost-effective manner.
• Recruit and structure a Facilities Maintenance staff and develop in-house expertise for critical process maintenance and operations functions.
• Prepare and implement recommendations to standardize Facilities Maintenance SOPs and related documentation.
• Implement and maintain a computerized maintenance management system to schedule, track, and document all preventive maintenance and repairs site-wide.
• Collaborate with other Operations groups to create and implement policies and provide resources to support process activities and production schedules.
• Ensure Self Inspection Universe procedures are in place and used in the area of responsibility.
• Initiate and track Environmental, Health, & Safety (EHS) adverse event investigations within 24 hours.
• Document and complete EHS RCAs within 5 days.
• Own the EHS risk assessment process within the management area and ensure CAPAs are implemented on time.
• Review ZAPs weekly, identify trends and CAPAs, and discuss with the team.
• Conduct routine EHS-focused process confirmations weekly in the area of management.
• Review area self-inspection reports monthly to identify recurring EHS issues and ensure effective CAPAs are implemented.

Qualifications

• Required: Bachelor‚Äôs degree
• Required: Experience with electrical, mechanical, process activities in a Biotech and/or pharmaceutical facility
• Required: Experience in facilities maintenance management
• Required: 5+ years experience with a biopharmaceutical company

Preferred Qualifications

• Graduate degree or advanced degree
• Production experience is a plus
• Familiarity with FDA and cGMP requirements and implementing procedures to meet guidelines
• Strong organizational skills
• Leadership experience including building design requirements, staffing organization, licensing and clinical operating procedures
• Stationary Engineers License ‚Äì State of Maryland (Preferred)
• EPA Certified Universal Refrigerant License (Preferred)
• Maryland Board of Waterworks & Waste Systems Operators License (Preferred)
• Maryland Board of Waterworks & Waste Systems Superintendents License (Preferred)

Education

• Bachelor‚Äôs degree