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

Required 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 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