Director, Maintenance and Metrology

Manage Preventative Maintenance/Calibration/Repair Program

• Responsible for a multi-site plan to support all Preventative Maintenance, Calibration and Repair activities


• Identify, Review, Approve, and Follow procedures for activities associated with Maintenance and Calibration to adhere to cGMP’s, company, local and state requirements.


• Identify, Collect, Review and Communicate metrics to all levels of the organization.


• Plan, Budget, and Review maintenance and calibration expenditures


• Provide oversight of shutdown activities and maintain systems for scheduling of calibration/PM/repair work.


• Ensure that work methods for facilities/utilities/HVAC/instrument systems troubleshooting are in place


• Ensure that maintenance and calibration tasks are completed, including review, in a timely manner

Increase Systems Uptime

• Drive evaluation of breakdown and calibration statistics to identify improvements


• Develop systems to increase overall equipment availability through reducing breakdowns.


• Ensure that corrective actions for out of specification operation and alarms are implemented


• Drive improvements in calibration activities to increase overall instrument performance


• Mentor staff on interpreting instrument calibration results and identifying appropriate corrective actions for out of specification conditions.


• Ensure that the spare parts stocking program is evaluated and executed

Lead Maintenance/Calibration Organization

• Develop and communicate performance metrics/goals


• Create systems to analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.


• Actively manage staffing plans to ensure coverage of manufacturing and lab operations.


• Identify training needs and evaluate personnel.


• Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.


• Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.


• Serve as site owner and subject matter expert of Maintenance and Metrology Practices


• Remain current on industry and FDA engineering standards and trends.

Interface with other groups

• Support Quality Assurance investigations of breakdowns and calibration failures.


• Ensure that clear communication with all customer groups happens


• Assure that maintenance/calibration activities do not impact cGMP compliance of facilities and systems.


• Coordinate complex equipment and instrument breakdown repair activities and serve as customer point of contact.


• Develop Project Justifications, including payback, and secure approvals for projects


• Assist with EHS activities when applicable and appropriate.


• Oversee and direct personnel and contractors engaged in equipment installation and facilities modifications

Manage Maintenance and Metrology Projects

• Work with other groups (Manufacturing, Quality, Supply Chain, Finance, etc.) to identify and develop process, quality and cost improvement projects that support business needs.


• Coordinate implementation of projects with Engineering, including execution of projects depending on scope.


• Review and accept engineering turnover packages (ETOP’s) as they are transferred to the Maintenance team.

Manage Service Providers Relationships

• Identify and maintain relationships with key Service Providers


• Ensure that agreements to ensure coverage of critical systems are in place

Minimum Requirements

• BS in a technical discipline (or equivalent experience)


• 15+ years of pharma (or regulated industry) experience


• 15+ years of experience in facilities, maintenance and/or engineering


• Solid background in facilities and project management


• Outstanding communication skills (verbal and written) to collaborate with multiple layers of organization in a dynamic environment


• Natural ability to be organized in how you think, communicate, and conduct your work


• Proven ability to quickly formulate and communicate concise, logical, fact-based information and make recommendations to internal and external stakeholders