Sr. Calibration Engineer

Description

The Senior Calibration Engineer is responsible for equipment management within master control and the planning, scheduling, and execution of calibration activities for the equipment and instruments in the calibration program. The role requires compliance with current regulatory / cGMP guidelines, standards, and policies.  

Requirements

Specific   Duties:

· Manage and maintain the current Equipment   List, the Equipment Preventive Maintenance system, the Calibration Instrument   List and Equipment Calibration systems within Master Control.

· At the beginning of each calendar year   prepare a draft schedule for preventive maintenance activities for laboratory   instruments, manufacturing equipment and reference instruments and share with   Process Development, MSAT, Quality Control, Manufacturing & Quality   Assurance.

· Coordinate preventive maintenance activities   with manufacturing activities.

· At the beginning of each calendar year   prepare a draft schedule for calibration activities for laboratory   instruments, manufacturing equipment and reference instruments and share with   Process Development, MSAT, Quality Control, Manufacturing & Quality   Assurance.

· Coordinate instrument calibration activities   with manufacturing activities.

· Update Process Development, MSAT, Quality   Control, Manufacturing & Quality Assurance when changes occur to the   annual preventive maintenance and calibration schedule.

· Assign and coordinate preventative   maintenance activities for laboratory instruments, manufacturing equipment   and reference instruments in accordance with the annual schedule.

· Undertake calibration activities for   laboratory instruments, manufacturing equipment and reference instruments in   accordance with the annual schedule.

· Maintain all calibration reference   instruments, including ensuring appropriate protection and storage conditions   of calibration reference instruments when not in use.

· Schedule, supervise and approve preventive   maintenance activities for laboratory instruments, manufacturing equipment   and reference instruments performed by outside vendors.

· Schedule, supervise, and approve calibration   activities for laboratory instruments, manufacturing equipment and reference   instruments performed by outside vendors.

· Where required, prepare laboratory   instruments, manufacturing equipment and reference instruments for shipping   to outside vendors.

· Operate, calibrate, and act as the primary   SME on the REES environmental monitoring system.

· Assist in the preparation, implementation,   and revision of preventative maintenance SOPs.

· Assist in the preparation, implementation,   and revision of preventative maintenance FORMs.

· Prepare, implement, and revise calibration   SOPs.

· Prepare, implement, and revise calibration   FORMs.

· Assist with investigations associated with   equipment preventive maintenance activities for laboratory instruments,   manufacturing equipment and reference instruments.

· Assist with investigations associated with   equipment calibration activities for laboratory instruments, manufacturing   equipment and reference instruments.

· Serves as a resource to other technicians in   the resolution of problems and issues.

· Maintain a clean and safe facility and   equipment.

· Other duties as assigned.

Education   and Experience Required:

· Associates degree, bachelor’s degree, or   appropriate experience

· Minimum 5 years of calibration experience.

· Experience working in a cGMP environment   preferred.

· Proficient in Microsoft Office products.

· Must be willing to work overtime as needed.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.