Title: Metrologist II

Location: NJ5-Totowa, New Jersey

Department: Radiopharmaceutical Contract Manufacturing

Training Curriculum: ID TCU.007

Overview: The Metrologist II is responsible for calibration and qualification tasks, and preventative maintenance of Quality Control, R&D, and manufacturing equipment, environmental monitoring instruments, ISO classified areas, and plant utilities within the pharmaceutical manufacturing plant. The individual will be responsible for commissioning and qualification of the new equipment. The individual will perform both in-house tests and will schedule external contractors for calibration work. The individual will support the Facility Engineer in executing preventative/corrective maintenance of plant equipment. This position will be reporting to the Facility and Equipment Engineer.

Essential Duties and Responsibilities
• Responsible to oversee the commissioning, qualification, calibration, and equipment requalification program. • Responsible to identify gaps in current calibration program/protocols and propose process changes to align with industry standards. Perform risk assessments respective to metrology strategies. • Responsible to plan, schedule, execute and review instrument calibration / qualification related activities according to the calibration procedure/master plan. Responsible to update calibration master plan for new equipment and for any changes for existing equipment • Responsible to schedule and supervise external contractors for initial qualification, recalibration, requalification work, preventative, and corrective maintenance. • Responsible to coordinate calibration work schedules with Analytical, R&D, microbiology and production personnel to minimize downtime. • Ensure equipment metrology is performed in a timely manner to prevent disruption of manufacturing or testing operations. • Perform review of the third-party calibration reports and/or requalification test results to ensure they meet specifications and acceptance criteria. Complete any required qualification documentation to bring the equipment ready to use. • Ensures equipment is maintained according to approved procedures. • Assist in compliance to the Quality Management System. • Responsible for troubleshooting equipment, malfunction or repairs and coordinating with the vendor or SME to complete required troubleshooting. Initiate work orders, completes Investigations, CAPAs, Deviation, and Change Control documentation for new and existing equipment and in general as required.Assist the Facility Engineer in instrument troubleshooting, investigation, and corrective actions. • Maintain approved gowning validation to allow access to classified manufacturing areas.Adhere to cGMP, EHS, and radiation safety procedures. Perform radiological checks of equipment prior to preventative maintenance/calibration activities in compliance with Sofie Radiation Protection Procedures and NJ State DEP regulations. • Ability to adapt to Sofie's culture and work well with cross-functional teams. • Demonstrate proficiency in the application of metrology principles used to calibrate benchtop analytical equipment such as precision balances, centrifuges, and pH meters; in addition to understanding mechanical and electromechanical principles that govern how specialized equipment operates (HPLC, radiation detectors, master-slave manipulators). • Perform other duties as assigned.

Qualifications
• Bachelor of Science required. Minimum of four-year degree in a technical discipline or equivalent military education and training, (ASQ Calibration Technician Certification (CCT) and/or military PMEL training is a plus, but not mandatory) 3-6 years of relevant Quality experience, understanding of calibration techniques and principles. • Experience in a GxP Manufacturing Environment preferred. Required greater than 3-year experience in cGMP Manufacturing Environment with a minimal 1 year in a metrologist role. • Experience in maintaining clean rooms, operation and troubleshooting/repair of small batch process equipment, Environmental Monitoring System (EMS), incubators, temperature-controlled chambers, and other common pharmaceutical manufacturing equipment is required. Experience in maintaining and calibration of Analytical instruments is required. • Experience with plant utilities: HVAC, chillers, boilers, required. Experience with high purified water systems, isolators and bio-safety cabinets is a plus but not required. • Ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, and high-pressure liquids and gasses required. • Excellent verbal and written communication skills required with the ability to work after hours and on call as needed required. • Proficiency in Microsoft Word and Excel required. Must be detail oriented and capable of completing required documentation in a timely manner, including work orders. • Knowledge of USP, FDA, and cGMP regulations is required. • Experience with computer system applications used to operate instruments and data acquisitions (Blue Mountain, Labware). Work experience with a LIMS system is highly desirable. • Experience with Lock out / Tag out practices. • Requires knowledge of fundamental quality concepts. • Must be able to lift up to 60 lbs. • Ability to perform Regulatory/Compliance Gap Assessment. • Any prior knowledge about any CMMS (Computerized Maintenance Management System) software is desired.