Job Description

Job Purpose:

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.

Essential Duties and Responsibilities:

• 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 escalate 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

Supplemental Functions:

· 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

Job Specifications and Qualifications:

• Specialized Technical Knowledge: Strong understanding of temperature loops, RTDs, thermocouples, load cells, conductivity sensors, and mass flow meters
• Aseptic Proficiency: Complete comfort working around high-temperature/high-pressure machinery (CIP/SIP systems) while strictly preserving cleanroom sterility boundaries
• System Integration Literacy: Ability to read and interpret complex piping and instrumentation diagrams (P&IDs), loop sheets, electrical schematics, and BFS OEM manuals
• Single-Site Ownership: High reliability to manage daily calibration routing autonomously across a single physical plant

Knowledge & Skills:

• Technical Degree in electronics or instrumentation (2yrs) and/or equivalent experience as calibration technician in the Pharmaceutical Industry or a regulated industry

• Knowledge of PLC logic and Controls

• Minimum 2 years calibration experience

• Microsoft Word, PowerPoint, Excel, Access

• Good communication, interpersonal, and organizational skills

• The ability to manage a multitude of resources and to be accurate and current with data and information

• The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity

• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition

• The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business

• The ability and willingness to change direction and focus to meet shifting organizational and business demands

• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals

• The ability to create new products and processes that add value to the business, by generating new ideas and applying creative and analytical approaches

• Specific expertise, skills and knowledge within calibration gained through education and experience

• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities

• The ability to take strategic objectives and accept accountability to drive results through effective actions

Education/Experience:

• Education: High school diploma required. Technical certification or Associate degree in Instrumentation, Industrial Electronics, Automation, or Metrology is highly preferred.
• Experience: 2+ years of hands-on calibration experience in a pharmaceutical 503B or another regulated environment. Direct experience troubleshooting BFS technology and automated utility loops is heavily weighted

Working Conditions / Physical Requirements:

• Position requires bending (waist to floor), climbing (2 to 4 feet), lifting (up to 50 lbs.), reaching, vision (20/20), standing for approximately 70% of the shift, walking across the manufacturing floor for 10%, and sitting/typing at a workstation for 20% to log asset data