Metrology And Calibration Technician

Description

The Metrology & Calibration Technician executes in-house calibrations, routine verifications, and diagnostics on critical manufacturing/instrument monitoring systems within a regulated cGMP drug facility. This role maintains the qualified state of production assets to ensure equipment accuracy and minimize downtime. Key responsibilities include managing scheduled calibrations for Blow‑Fill‑Seal (BFS) aseptic packaging systems and critical instruments ranging from environmental sensors to weight and pressure systems.

All activities must strictly comply with cGMP standards, NIST traceability guidelines, and internal SOPs.

The Metrology & Calibration Technician executes in-house calibrations, routine verifications, and diagnostics on critical manufacturing/instrument monitoring systems within a regulated cGMP drug facility. This role maintains the qualified state of production assets to ensure equipment accuracy and minimize downtime. Key responsibilities include managing scheduled calibrations for Blow‑Fill‑Seal (BFS) aseptic packaging systems and critical instruments ranging from environmental sensors to weight and pressure systems.

All activities must strictly comply with cGMP standards, NIST traceability guidelines, and internal SOPs.

• Instrument Calibration:
  Performs in-house scheduled and unscheduled calibrations on critical instrumentation, and equipment monitoring devices that affect product quality including temperature and humidity controllers, autoclaves, pressure transducers, pH meters, check‑weighers, ovens, and cells, following established standard test methods
• BFS Equipment Calibration:
  Perform precision calibrations on critical instrumentation embedded within Blow‑Fill‑Seal (BFS) machinery, focusing heavily on product temperature probes, sterile air pressure sensors, parison thickness controls, and vacuum transducers
• Automation Loop Verification:
  Interfaces with programmable logic controller (PLC) systems and human‑machine interfaces (HMI) – Panasonic, B & R, and Bosch Rexroth platforms to execute precise loop calibrations and system verifications
• Cleanroom Compliance:
  Adheres strictly to aseptic protocols, environmental controls, and cleanroom behaviors to prevent product contamination when entering, working within, or servicing equipment inside classified environments
• Material Control:
  Strict adherence to decontamination and sanitization procedures for all tools, calibration standards, and components introduced into cleanroom environments
• Technical Troubleshooting:
  Diagnose and realign physical assets, control valves, loop controllers, and electronic transmitters when instrument drift occurs
• Good Documentation Practices (GDP):
  Complete precise calibration data sheets, equipment logs, and electronic work orders inside the CMMS immediately following a service, capturing critical "as‑found" and "as‑left" data
• Out‑of‑Tolerance (OOT) Investigation:
  Document and expedite Out‑of‑Tolerance events immediately, providing engineering with the detailed data required to assess risks to active BFS production batches
• Standards Management:
  Keep secondary test standards (dry blocks, pressure modules, and multimeters) in peak condition, ensuring they stay calibrated and traceable to NIST
• Data Management & Tracking:
  Utilizes Blue Mountain RAM and Indy Soft computerized maintenance management (CMMS) systems to schedule calibration events, input accurate data logs, track assets, and manage historical equipment records in strict compliance with ALCOA+ data integrity standards

• Assists in programming Blue Mountain RAM by writing measurement data templates (MDTs) and scheduling calibration events within the software as new instrumentation is inducted
• Assists with Blue Mountain RAM implementation by training BFS maintenance technicians with hands‑on use
• Attends Blue Mountain hands‑on training as necessary to assist other departments during implementations
• Performs other similar duties as required

• Specialized Technical Knowledge:
  Strong understanding of temperature loops, RTDs, thermocouples, load…