Experience working within a GxP regulated manufacturing or laboratory environment.
An understanding of FDA: 21CFR Part 211, ISPE: GAMP 5, ISO 17025, National Institute of Standards and Technology.
Strong understanding of Asset Management systems in relationship to creating work plans, calibration measurement data templates, reports and other activities needed for a strong equipment program.
Day to day equipment operations for calibration and preventive maintenance (planning, scheduling, executing, documenting, etc.).
Provide support in the investigation of equipment related deviations.
Verify equipment compliance with established standards and specifications.
Improve routine calibration and maintenance activities on equipment to ensure optimal performance and longevity.
Collaborate with stakeholders to plan and schedule calibration, maintenance and qualification activities while minimizing equipment downtime.
Provide guidance and technical support to less-experienced technicians.
Coordinate and schedule equipment activities with service providers as needed.
Diagnose and repair faulty equipment or coordinate repairs with external service providers.
Understand HVAC and building automation systems in relationship to pressure cascade, temperature, and humidity.
Capable of setting up and maintaining the Continuous Monitoring system, to include alarm management and reports.
Evaluate needs for procurement of equipment, tools and parts needed for calibration, preventive maintenance, and qualification activities.
Inventory management, spare parts identification, and sourcing.
Develop quotes for submission of purchase requisitions for goods and services related to equipment calibration, maintenance, and qualification activities.
Monitor work plans and support the organization of team time efficiently, prioritizing workload and reporting challenges to the supervisor.
Effectively communicate and express ideas written and verbally in individual and group situations.
Ability to work independently or as a team member.
Lead by example.