Manager, Metrology

Manage Preventative Maintenance/Calibration/Repair Program

• Prepare, maintain, and follow procedures for the calibration and metrology systems and associated processes to adhere to cGMP’s, company, local and state requirements. 


• Maintain, review and communicate metrics to all levels of the organization.


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


• Coordinate shutdown activities and scheduling of calibration work.


• Develop, conduct and document test methods for instrument systems troubleshooting


• Review Calibration Paperwork.


• Evaluate breakdown and calibration statistics and adjust plans to suit.


• Monitor calibration operations and implement corrective actions for out of specification results.


• Increase overall instrument performance through optimization of calibration activities.


• Monitor instrument calibration results and implement corrective actions for out of specification conditions.


• Optimize spare parts stocking program for instruments


• Assess staffing levels against requirements and production needs.


• Support Quality Assurance investigations of calibration failures.


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


• Facilitate completion of change control documentation.


• Ensure that calibration files are maintained.


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


• Serve as site owner and subject matter expert of Work Order system.


• Serve as subject matter expert on the Calibration systems


• Prepare and manage shutdown schedules.


• Develop and implement improvements through cross-functional interactions.


• Develop, review, revise, and maintain SOPs for all Metrology/Calibration processes.


• Ensures compliance with environmental regulations and works to reduce physical hazards in the facility by performing duties personally or through subordinates


• Assist with EHS activities when applicable and appropriate.

Supervise Calibration Technicians

• Provide day to day supervision including oversight of work quality.


• Manage staffing levels to ensure coverage of manufacturing and lab operations.


• Develop training and evaluate personnel.


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


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

Coordinate Service Providers

• Manage contracts to ensure appropriate service levels at acceptable cost levels.


• Establish agreements to assure coverage of critical systems.


• Oversee technical quality of work performed.


• Ensure that work performed by service providers meets regulatory expectations.

Coordinate Handover of Equipment from Engineering

• Work with engineering team to review specifications and provide input


• Accept turnover packages and establish maintenance programs.

Secondary Responsibilities and Functions:

• Excellent leadership skills with the ability to work with multiple teams


• Ability to navigate through ambiguity and rapid growth and adapt to change


• Adapts departmental plans and priorities to address resource and operational challenges


• Outstanding communication skills (verbal and written) to collaborate with Senior Management 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

Education/Training:

• AS or BS in a technical discipline (or equivalent experience)

Experience:

• 10+ years of calibration experience

Skills/Abilities:

• 7+ years of industry experience in managing regulated facilities, maintenance and calibration personnel


• Solid background in facilities and project management