Calibration and Electronic Technician I
PharmaRegulatory AffairsQuality Assurancegmpcro
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heights Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Summary: Responsible for the calibration system at the site; performs all calibrations or soliciting the required services from an outside vendor. Implement and support Good Manufacturing Practices areas; processing, packaging and facility instrument calibration with an in-house Patheon calibration program. Manage calibration documentation review, change controls and deviation records. Essential Functions: Perform in house calibration on most of the plant equipment Maintain plant service equipment and keeps logs as required Perform regular Electronic/Electric Preventive Maintenance (PM) Act as a Fire Crew member Attend to regular electrical/electronic breakdowns and regular service calls Involved in upgrading/new installation and commissioning new equipment Maintain all calibration and PM records. Calibrate electrical/pneumatic sensors, indicators and transmitters for process parameters like temperature, pressure, humidity, pH, conductivity, force etc. Review calibration and preventive maintenance work orders for compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs), and issue appropriate change controls. Analyze process instruments for potential calibration problems and support further troubleshooting of process problems and effectively communicate equipment status, operational impact, potential risks and solutions to Supervisor/Manager. Troubleshoot deviations and repairs or replaces defective instruments. Perform repairs and maintenance as needed and support maintenance department in effective resolutions of process equipment problems. Review and update existing calibration SOPs and prepare new SOPs as and when required. Help investigate audit observations for calibration work and explain various deviations with supporting documents. Schedule and complete calibration work on time through effective coordination with processing department or external contractors while ensuring calibration system is compliant to regulatory bodies, clients and industrial practices. Initiate/update quality investigations for calibration failure and help complete corrective/preventive actions items on time. Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work as well as requirement to work during maintenance shutdowns. REQUIRED QUALIFICATIONS Education: High school diploma/General Educational Development (GED) Certificate is required Certification in electronic instrumentation. Industrial electricians license would be an asset. Experience: Minimum 2 years of previous calibration and electronics experience in a controlled and regulated environment, preferably in a pharmaceutical environment. Equivalency : Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Experienced in using various calibration equipment, calibration standards and electronic test equipment. Demonstrated knowledge of metrology principles and industrial instrumentation. High level of trouble-shooting capability. Detail oriented with a focus on superior documentation skills. Self directed and able to work independently. Ability to effectively communicate and coordinate equipment downtime. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language. Standards and Expectations: Follow all E
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