About us

SOFIE Co. (SOFIE), is one of the major PET radiopharmaceutical suppliers in the U.S. and leads the industry in our focus on the development of radioisotopes to advance the diagnosis and treatment of disease. The Company, headquartered in Dulles, Virginia, operates 14 radiopharmaceutical product facilities nationwide.

Title: Metrologist
Location : Totowa, NJ5

Overview

The Metrologist is responsible for calibration, qualification tests, and preventative maintenance of manufacturing equipment, environmental monitoring instruments, ISO-classified areas, and plant utilities within the pharmaceutical manufacturing plant. 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 report to the Facility and Equipment Engineer.

Essential Duties and Responsibilities

• Develop and oversee the calibration and equipment requalification program.
• Plan, schedule, execute and review instrument calibration/qualification-related activities according to the calibration procedure/master plan.
• Schedule and supervise external contractors for recalibration work, preventative, and corrective maintenance.

Coordinate calibration work schedules with Analytical, R&D, and production personnel to minimize downtime.

• Ensure equipment metrology is performed in a timely manner to prevent disruption of manufacturing or testing operations.
• Review third-party calibration reports and/or requalification test results to ensure they meet specifications and acceptance criteria.
• Ensures equipment is maintained according to approved procedures.
• Assist in compliance to the Quality Management System
• Initiates and completes Investigations, CAPAs, Deviation, and Change Control documentation
• Assist the Facility Engineer in instrument troubleshooting, investigation, and corrective actions.
• 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 the cross-functional team.

Qualifications

• Metrologist I – Bachelor of Science is preferred. Minimum of a two-year degree in a technical discipline A.S. or A.A.S), or equivalent military education and training, (ASQ Calibration Technician Certification (CCT) and/or military PMEL training is a plus, but not mandatory) 1-3 years of relevant experience in a pharmaceutical environment, understanding of calibration techniques and principles.
• Metrologist II - Bachelor of Science required. Minimum of a 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.
• Metrologist III - Bachelor of Science required. Minimum of a 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) 6+ years of relevant Quality experience, understanding of calibration techniques, and principles.
• Experience in a GxP Manufacturing Environment preferred.
• Experience in maintaining clean rooms, operation, and troubleshooting/repair of small-batch process equipment, Environmental Monitoring Systems (EMS), incubators, temperature-controlled chambers, and other common pharmaceutical manufacturing equipment.
• Experience with plant utilities: HVAC, chillers, boilers, required. Experience with highly purified water systems, isolators, and bio-safety cabinets is a plus but not required.
• Radiopharmaceutical Contract Manufacturing (RCM) – NJ5

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Relocation assistance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Evening shift
• Monday to Friday
• Weekend availability

Ability to commute/relocate:

• Totowa, NJ: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:

• military PMEL training (Preferred)
• pharmaceutical environment (Required)
• understanding of calibration techniques and principles (Required)

License/Certification:

• ASQ Calibration Technician Certification (CCT) (Required)

Work Location: In person

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