Job Description

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Position Summary:

The Calibration/Instrument Technician initiates, coordinates, and administers the calibration program for the Monroe facility and conducts/coordinates the inspection, calibration, and repair of all instruments, equipment and systems used for the manufacture and measurement and determination of quality of pharmaceutical products in accordance with current industry regulations and practices in the U.S.A. and the state of North Carolina.

• Under the direction of the maintenance engineer or Engineering management, the calibration/instrument technician will plan, schedule, conduct and record planned and unplanned inspection, troubleshooting, maintenance, and calibration of instruments, tools, equipment and laboratory and water systems in any area of the plant. This includes initiation and administration of the plan wide calibration program. Keep manufacturing and laboratory staff and management team of notified of calibration status of all instruments in the program. Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems.
• Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems. Track and maintain up to date the calibration status and records of all instruments, equipment, and tools.
• Troubleshoot automation and instrumentation problems for manufacturing and laboratory equipment.
• Organize and maintain the calibrations bench / lab.
• Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems
• Identify, tag, and write calibration instructions, schedule and conduct all calibrations. Identify and initiate procurement of all tools, equipment, and calibration standards to be used for the maintenance, troubleshooting, and calibration program.
• Conduct general maintenance, repairs and upgrades or replacements to facility instruments and scales.
• Under the direction of the maintenance engineer or Engineering management, the calibration/instrument technician will plan, schedule, conduct and record planned and unplanned inspection, troubleshooting, maintenance, and calibration of instruments, tools, equipment and laboratory and water systems in any area of the plant. This includes initiation and administration of the plan wide calibration program. Keep manufacturing and laboratory staff and management team of notified of calibration status of all instruments in the program. Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems.
• Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems. Track and maintain up to date calibration status and records of all instruments, equipment, and tools.
• Troubleshoot automation and instrumentation problems for manufacturing and laboratory equipment.
• Organize and maintain the calibrations bench / lab.
• Independently identify, prevent and solve technical problems related to calibration of laboratory and manufacturing measuring instruments, equipment and systems.
• Identify, tag, and write calibration instructions, schedule and conduct all calibrations. Identify and initiate procurement of all tools, equipment, and calibration standards to be used for the maintenance, troubleshooting, and calibration program.
• Conduct general maintenance, repairs and upgrades or replacements to facility instruments and scales.
• Will identify, communicate and cooperate/guide internal and third party calibration services providers and provide technical support during process maintenance and services to the facility and its equipment. Will inspect and maintain systems in accordance with current ASTM standards, FDA guidance, internal SOP’s and industry practice. Review all calibration certificates from third party services to ensure compliance with our procedures.
• Track and maintain record and conduct sampling and coordinate testing of purified water and water for injection systems.
• Conduct timely planned preventive maintenance and unplanned repairs and calibration completing documentation as required by local SOP’s.
• Support other maintenance technicians and engineers in the conduct of their work. Support maintenance and troubleshooting of electrical and PLC controlled equipment.
• Participate in equipment user requirement specification discussions.
• Domestic and international travel up to 5% may be required to accompany technical staff in the factory acceptance and inspection of equipment.
• Maintain trained and certified status as required in cGMP, HR and industry procedures as required.
• Conduct maintenance and repair activities based on internal SOP’s and engineering manager direction. Supervises plant access and work of outside service contractors.

Education/experience:

• Preferably 5 years’ experience providing calibration services in a pharmaceutical manufacturing or testing laboratory.
• Associate degree in instrumentation or electronics and industrial/electronic controls or equivalent experience.
• Familiarity with ASME codes.
• Position requires an understanding and experience with industrial and laboratory instruments and controls, troubleshooting and repair.
• Practical, relevant and significant related experience in pharmaceutical industry of various dosage manufacturing processes and equipment desired.
• Experience implementing and evaluating contracted work of outside maintenance and calibration service providers, suppliers and maintaining successful partnerships.

Skills:

• Familiarity with pharmaceutical laboratory and manufacturing instruments and equipment and their calibration.
• Good understanding of industrial automation controls.
• Proficient verbal and written communication skills in English language.
• Careful and methodical analytical thinking and problem solving.

Abilities :

• Able to work well in a team-oriented environment; critical thinking and problem solving, results oriented, decision making, team building, able and willing to support peers
• Able to organize, prioritize, and successfully repair, calibrate instruments and complete multiple projects, tasks, and issues in a timely manner.
• Functions independently in periods of supervisor’s absence.

Knowledge:

• Understanding of the current calibration practices and requirements for instruments, controls, and water systems in a pharmaceutical industrial facility and laboratory in accordance with ASME codes and National Electrical Code.
• Complete familiarity with calibration practices, tools and skills electricity and their use for conducting calibration, pharmaceutical facility purified water and water for injection systems, and chemical laboratory instruments calibration.

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