Role Title: Facilities Calibration Technician

Department: Facilities

Supervisor: Director of Facilities

FLSA: Exempt

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

ROLE SUMMARY

The Facilities Team Calibration Technician’s primary responsibility is to track, perform and document the required instrumentation activities including calibration, troubleshooting, installation and repairs in cGMP manufacturing environment. This includes all process equipment, process utilities plus building utilities to maintain the site in a safe and cGMP compliant state. Provide training and direction to the Facilities staff plus other departments on the calibration program and the individual calibration and repair activities as necessary. Develop, review, and update the procedures and work plans associated with calibrations and safety procedures that support the site. Review instrument tolerances against process requirements and calibration standards and provide recommendations on changes to Manufacturing & QA to ensure product safety. Work with vendors as required to maintain the calibrated instruments in tolerance and operational.

ROLE RESPONSIBILITIES

Promote a positive “can do” attitude and work ethic.
Perform calibration and unplanned repairs on the instrumentation in the calibration program following company SOPs and other work instructions.
Initiate and write and review deviations, CAPA’s and change controls for calibrated instruments.
Write, edit, and review Calibration procedures for individual instrument calibrations to ensure accuracy, repeatability, and compliance.
Perform shipping & return of Instrumentation Standards and other instruments to off-site calibration vendors for routine calibrations and repairs.
Support validation activities as required.
Conduct routine inspections and monitoring of equipment and systems as well as documenting operating parameters.
Provide general calibration services throughout all areas of the facility.
Complete GMP and other controlled documentation, including input into the Computer Maintenance Management System (CMMS).
Follow established safety and environmental guidelines and procedures for all work performed.
Fosters and practice a positive safety culture.
Provide prompt, consistent, and orderly work habits.
Provide troubleshooting skills & ability typical in a pharmaceutical fermentation manufacturing facility.
Available to work overtime when necessary.
General knowledge of shop tool operation and safety.
Work in clean room manufacturing environments requiring gowning in the form of scrubs, gowns, gloves, and steel toe boots be worn.
May require working with electrical systems 480VAC and below.
Work with hazardous materials and chemicals.
CMMS “Blue Mountain” input and closure of assigned work orders.
Assist in maintaining & planning the routine work schedule for Facility activities.
Communicate with vendors as required for obtaining parts quotes necessary to maintain the instruments and equipment, plus issue supply request for purchase order issuance.
Participate in Team Audits for EH&S and other audits as required.
Highly organized with a strong attention to detail.
Strong communication skills (verbal and written)
Works well independently and in a team environment.
Support Department and Company objectives with other duties as required.

QUALIFICATIONS

High school diploma/GED required. Associates degree preferred.
5 plus Years in cGMP pharmaceutical manufacturing facility preferred.
3plus Years with extensive experience in calibration/ instrumentation discipline.
Experience with Program Logic Controllers (PLC) troubleshooting desired.
Familiarity with Ladder Logic a plus.
Familiarity with Building Automation Systems preferred.
Familiarity with HART protocol, DMMs (Fluke 744/754) preferred.
Ability to read and interpret engineering drawings (P&ID’s) and specifications.
Knowledge of mechanical, pneumatic, hydraulics, refrigeration, steam, electrical systems, and maintenance methods are preferred.
Background and/ or knowledge of EH&S programs desired.
PC Literacy with advanced skills in Microsoft Outlook, Word, Excel, and Power Point desired.
Able to climb and work at heights up to 30 feet with proper PPE.
Able to lift up to 50lbs.
Able to be respirator certified and wear during performance of some job functions.

Polaris Pharmaceuticals Inc.

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Facilities Calibration Technician