This position will manage, supervise and coordinate the work of the calibration/metrology group to ensure that the facility instrumentation is calibrated properly and on schedule to comply with good calibration/metrology guidelines. Work independently to create a robust Calibration and Preventative Maintenance program and Data Management System. Ensure that the facility equipment and instrumentation are properly maintained and calibrated on schedule to comply with good practice guidelines. Responsible for maintenance, troubleshooting, calibration and repair on a variety of complex equipment used for manufacturing, laboratory or calibration/metrology applications.
1. Manage the process of scheduling resources and personnel to ensure all guidelines and policies are adhered to, and provide adequate customer service
2. Develop Calibration Metrology and Preventative Maintenance systems for facilities, utilities and equipment in cGMP environment and maintain system as needed
3. Maintain systems including updating documentation, equipment parts list, out-of-tolerance reports and investigations
4. Provides proper oversight and execution of maintenance and/or calibration for instruments or equipment
5. Investigate major instrument or equipment related problem areas and determine best course of action for resolution, including out-of-tolerance reports and investigations
6. Generate ideas and suggestions for reducing calibration turnaround time
7. Work with equipment vendors to schedule, perform and review reports for equipment maintenance and calibration
8. Assist engineers with determination of calibration and maintenance requirements for new or changed equipment
9. Schedule and work around availability of equipment, effectively collaborating with cross-functional departments
10. Ensure maintenance and calibration histories are easily retrievable to support regulatory inspection requirements
11. Develop techniques as necessary to ascertain that newly acquired or developed Measurement and Test Equipment performs in accordance with required specifications
12. Strategically assesses client environments, needs, and requirements to develop and initiate effective solutions and through established solid relationships with clients, delivers successful execution.
13. Perform other duties as required
• Bachelor’s Degree in Engineering or related field
• Minimum of 8 years’ experience in metrology
• Some experience in equipment maintenance
• Special training in the calibration of pressure, temperature humidity, participate, voltage current, air samplers, dimensional, mechanical and physical devices
• Proficient in Microsoft applications
• Experience working in asset management software preferred
• Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing
• Position requires the ability to work with mechanical equipment and lift up to 30 lbs.
• Must be able to work in both cleanroom and chemical laboratory environments.