About the position
The Engineering, Maintenance and Site Services (EMSS) organization continuously improve the reliability of the Durham Site operations and provides the best in class services with the final goal of delivering our high-quality vaccines to the patients around the world. With our core principle of Safety First and Quality Always, EMSS strives to have the safest and most compliant operation around the network. EMSS has an Associate Director opening for the Vaccine Manufacturing Facility (VMF) maintenance team. The selected candidate will manage the engineering, maintenance and calibration activities related to the two Filling lines within this facility. The main equipment within these two Filling lines consist of Vial washers, Depyrogenation Tunnels, Fillers with Isolator technology, Lyophilizers, Visual Inspection Machines along with all the support equipment prep and clean utilities. Strong technical and customer service-oriented leader to support the VMF IPT. Will lead the tactical and strategic equipment reliability improvements, human resources activities while ensuring a safe work environment with optimized product quality and manufacturing processes and regulatory compliance.
Responsibilities
- Provides leadership and direction through individual contributors.
- Executes functional business plans and contributes to the development of group strategies.
- Prioritizes based on compliance, departmental budget and profit plan to address resource and operational challenges.
- Leverages relationships with key clients and/or customers to support business needs.
- Coaches/mentors direct reports responsible for their area within Engineering, Maintenance & Calibration.
- Ensures proper team capabilities with appropriate trainings.
- Manages the area succession plan.
- Manages the VMF Maintenance cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year.
- Responsible for major equipment related projects, including funding, change control and equipment qualification within their area.
- Responsible for obtaining bids, reviewing contracts, supervising, and providing follow-up on contract work including the auditing of time and material reports for their area.
- Responsible for assisting with master shutdown schedules and shutdown execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdowns.
- Coordinates activities with stakeholders and project owners.
- Attends shutdown meetings ensuring activities are tracked and completed.
- Responsible for the preventive maintenance and calibration programs of all production equipment.
- Daily support of all production equipment to ensure area safety, compliance, production and financial goals are met.
- Conducts spare parts risk-based assessments and identification of new parts to replace obsolescent parts.
- Establishes processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities.
- Manages equipment location, documentation and status in SAP as well as related equipment drawings.
- Assists in deviation investigations for maintenance instruments, equipment, and systems.
- Collaborates/Executes with the reliability engineers periodic risk assessments and owns area reliability actions.
- Collaborates with Automation and Vendors for maintenance and troubleshooting equipment.
- Monitors calibration, maintenance, and equipment/utilities operations performance by analyzing completed work orders.
- Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.
- Identifies revisions, deletions, or additions to the calibration and maintenance programs.
- Monitors KPIs (MTTR, MTBF, Uptime, etc.) to ensure accuracy and drives mitigating actions.
- Develops and executes proven predictive and condition-based maintenance programs focusing on proactive risk mitigation.
Requirements
- Bachelor's Degree in Engineering, Science or related technical field.
- Minimum 8 years of progressive Maintenance Engineering and Leadership experience in cGMP Maintenance/Engineering Discipline (6 Years with a master's degree or MBA: 3 years with a PhD), or relevant military service.
- Experience in Maintenance Supervisor/Manager, Reliability or Maintenance Engineering, Utilities Maintenance.
- Experience in introducing Reliability Engineering for Maintenance (RCM, FMEA, Criticality Analysis, PM optimization, RCA, etc.).
- Strong planning, scheduling, and time management skills.
- Working knowledge of regulatory requirements in accordance with cGMP manufacturing operations.
- Good oral and written communication skills.
- Project management, including change control and equipment qualification.
Nice-to-haves
- 15 years of Maintenance and Military experience in a GMP regulated industry in the Maintenance field.
- SAP experience related to plant maintenance and spare parts procurement systems.
- Experience running a Reliability Engineering program.
- At least four years of experience in military service.
