Metrologist

Job Description 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 equipmentPerforms 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 performedProvide recommendations for instrumentation / metrology spare parts and PM proceduresWork 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 complianceAssist in the maintenance and review of calibration standards and vendor calibration documentationWork with contract service providers and support contractors executing calibration and metrology activitiesProvide support to other departments to troubleshoot, test, repair and optimize instruments, equipment and control systemsProvide support for IQ/OQ and PQ of new systems throughout the facilityRequired Qualifications and Skills: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 equivalentKnowledge of current industry expectations of validation requirements for equipment validation and qualificationTechnical 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 chambersFlexibility to work outside of business hours, should issues ariseKnowledge of Quality systemsSpeaks, writes, listens and presents information in a logical and articulate manner appropriate for the audienceAble to multi-task productively, well organized, effectively applies time management processes and proceduresAbility to recognize what needs to be done, taking action, and accomplishing results as the situation demandsPowered by JazzHRVHqDwRhK9E