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Sr. Calibration Technician

Employer
Polaris Pharmaceuticals, Inc
Location
95688, Vacaville
Start date
Sep 9, 2022

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Job Details

Role Title Senior Calibration Technician

Department Facilities

Supervisor Director of Facilities

FLSA Exempt

CORE VALUES

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

FUNCTION SUMMARY SeniorCalibration Technician

The Senior Facilities Team Calibration Technician’s primary responsibility is to track, perform, and document the required instrumentationactivities 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 calibrationrepair activitiesas necessary. Develop, review, and update the proceduresand 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 toensure product safety.Work with vendors as required to maintain the calibrated instruments in tolerance and operational.

Duties & Responsibilities:

1)Promote a positive “can do”attitude and work ethic.

2)Perform calibration and unplanned repairs on the instrumentation in thecalibration program following company SOPs andother work instructions.

3)Initiate, write, and review deviations, CAPA’s and change controls for calibrated instruments.

4)Write, edit, and review calibration procedures for individual instrument calibrationsto ensure accuracy, repeatability, and compliance.

5)Perform shipping & return of Instrumentation Standards and other instruments to off-site calibration vendors for routine calibrations and repairs.

6)Support validation activities as required.

7)Conduct routine inspections and monitoring of equipment and systems as well as documenting operating parameters.

8)Provide general calibration services throughout all areas of the facility.

9)Complete GMP and other controlled documentation, includinginput into the ComputerMaintenance Management System (CMMS).

10)Followestablished safety and environmental guidelines and procedures for all work performed.

11)Fosters and practice a positive safety culture.

12)Provide prompt, consistent, and orderly work habits.

13)Provide troubleshooting skills& ability typical in a pharmaceutical fermentation manufacturing facility.

14)Available to work overtime when necessary.

15)General knowledge of shop tool operation and safety.

16)Work in cleanroom manufacturing environments requiring gowning in the form of scrubs, gowns, gloves, and steel toe boots be worn.

17)May require working with electrical systems 480VAC and below.

18)Work with hazardous materials and chemicals.

19)CMMS “Blue Mountain”input and closure of assigned work orders.

20)Assist in maintaining and planning the routine work schedule for Facility activities.

21)Communicate with vendors as required for obtaining parts quotes necessaryto maintain the instrumentsand equipment, plus issue supply request for purchase order issuance.

22)Participate in Team Audits for EH&S and other audits as required.

Education & Experience

•High school diploma/GED required. Associates degree preferred. •5 plus years in cGMP pharmaceutical manufacturing facility preferred. •3 plus 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.

Skills & Competencies

•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. •Ability to read and interpret engineering drawings (P&IDs) and specifications.•Knowledge of mechanical, pneumatic, hydraulics, refrigeration, steam, electrical systems, and maintenance methods are preferred. •Background and/orknowledge of EH&S programs desired.•PC Literacy with advanced skills in Microsoft Outlook, Word, Excel, and PowerPoint desired. •Able to climband work at heights of upto 30 feet with proper PPE.•Able to lift up to 50lbs. •Able to be respirator certified and wear during performance of some job functions.

Company

Polaris Group is a multinational biotechnology company focused on developing novel anti-cancer therapies. Our lead drug candidate, Pegargiminase (ADI‑PEG 20), is a biologic in late-stage clinical development for a wide range of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others. Polaris Group is involved in every stage of the drug development process. Our family of companies harnesses structure-based drug design technology to create novel oncology therapies, conducts clinical studies at top-tier cancer centers worldwide and operates cGMP Production Facilities in Northern California and China
 

Stock Exchange: Taiwan

Stock Symbol: 6550.TDW
 

Find Us
Website
Phone
707-451-0441
Location
4941 Allison Parkway, Suite B
Vacaville
CA
95688
United States
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