Metrologist

MedPharm•Durham, NC

About The Position

This position contributes to the company success by providing calibration and instrumentation oversight for lab equipment through executing scheduled calibrations and preventative / corrective maintenance in compliance with GMP regulations and internal procedures. Summary of Key Responsibilities: Maintain and perform corrective, preventative maintenance calibrations on GMP and non-GMP equipment Performs maintenance, testing, troubleshooting, calibration, and repair of electrical circuits, components, analytical instruments, and pharmaceutical laboratory and manufacturing equipment. Maintains all logs and required documentation. Writes Out-Of-Tolerances (OOT’s) and Deviations. Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects. Entering and updating CMMS system information relevant to calibrations performed Provide recommendations for instrumentation / metrology spare parts and PM procedures Work closely with Validations and Stability Manager, Lab Operations, Manufacturing and Quality to ensure strict compliance with GMP guidelines, specifically to ensure that equipment is maintained in GMP compliance Assist in the maintenance and review of calibration standards and vendor calibration documentation Work with contract service providers and support contractors executing calibration and metrology activities Provide support to other departments to troubleshoot, test, repair and optimize instruments, equipment and control systems Provide support for IQ/OQ and PQ of new systems throughout the facility

Requirements

B.S., in a scientific or engineering discipline, with 2-5 years of relevant GMP pharmaceutical experience, or an Associate's Degree in a relevant technical discipline with 5+ years of GMP pharmaceutical or equivalent
Knowledge of current industry expectations of validation requirements for equipment validation and qualification
Technical ability to problem solve and troubleshoot equipment systems in a pharmaceutical environment, including but not limited to: HPLCs, balances, pH meters, HVAC, chart recorders and stability chambers
Flexibility to work outside of business hours, should issues arise
Knowledge of Quality systems
Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience
Able to multi-task productively, well organized, effectively applies time management processes and procedures
Ability to recognize what needs to be done, taking action, and accomplishing results as the situation demands

Responsibilities

Maintain and perform corrective, preventative maintenance calibrations on GMP and non-GMP equipment
Performs maintenance, testing, troubleshooting, calibration, and repair of electrical circuits, components, analytical instruments, and pharmaceutical laboratory and manufacturing equipment.
Maintains all logs and required documentation.
Writes Out-Of-Tolerances (OOT’s) and Deviations.
Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects.
Entering and updating CMMS system information relevant to calibrations performed
Provide recommendations for instrumentation / metrology spare parts and PM procedures
Work closely with Validations and Stability Manager, Lab Operations, Manufacturing and Quality to ensure strict compliance with GMP guidelines, specifically to ensure that equipment is maintained in GMP compliance
Assist in the maintenance and review of calibration standards and vendor calibration documentation
Work with contract service providers and support contractors executing calibration and metrology activities
Provide support to other departments to troubleshoot, test, repair and optimize instruments, equipment and control systems
Provide support for IQ/OQ and PQ of new systems throughout the facility