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| Perform preventative maintenance, repair, and calibration necessary to result in production equipment that is in good working condition, in accordance with corporate policies and in compliance with GMP and the DiaSorin Quality Policy.
- Develop and implement operating, inspection and preventative maintenance procedures for equipment to assure compliance with GMP, FDA, OSHA, ISO, or other established guidelines.
- Schedule and perform necessary preventative maintenance, calibration and repair of production equipment and mechanical, pneumatic, and electrical systems to meet specifications where established.
- Maintain records of preventative maintenance in accordance with DiaSorin policies.
- Coordinate servicing of equipment with outside vendors where necessary and monitor their compliance with established corporate policies and guidelines
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| Perform and assist in identifying specifications, sourcing, installation, and validation of new, used, and modified production equipment to ensure it meets appropriate requirements
- Identify, evaluate and recommend value added capital expenditures which result in cost reduction and/or quality improvements to production equipment and processes.
- Identify engineering specifications and make recommendations for process and equipment modifications.
- Perform as liaison between DiaSorin and outside vendors / contractors when required.
- Perform and assist with installation, operation, and performance qualifications where required.
- Perform and assist in writing final reports for the validation process.
- Provide ongoing troubleshooting services and support for production equipment and/or processes.
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| Understand and utilize documentation protocols, and accurately and legibly complete all documentation on time to result in a product/process history consistent with GMP requirements and the DiaSorin Quality Policy.
- Understand and apply appropriate procedures pertaining to the work to be performed.
- Understand and accurately complete in a timely fashion, documents to include preventative maintenance system work requests, equipment maintenance files, and engineering project log file.
- Route, handle and/or store completed documentation appropriate for the work completed.
- Accurately initiate Engineering Change Orders and NCR/Deviations as applicable.
- Follow DiaSorin established compliance procedures designed to ensure that all regulatory requirements are met. Activities may include audits, documentation, and the understanding of the requirements of agencies such as ISO, OSHA, EPA, NRC, and FDA.
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| Perform work in a safe manner consistent with DiaSorin's Health, Safety and Environmental policies. Assume responsibility for personal safety and that of co-workers to result in a safe work environment for all employees and the protection of the environment and the community at large.
- Follow DiaSorin's established policies and procedures for the safe handling and disposal of hazardous, radioactive and infectious material.
- Participate in DiaSorin's safety training programs and demonstrate competency in the use of Material Safety Data Sheets, chemical labeling, corporate emergency response procedures, and DiaSorin's Health, Safety, and Environmental policies.
- Be aware of and understand the hazards specific to the work area and follow appropriate safety precautions necessary to control them.
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Participate in training and educational endeavors designed to develop a highly skilled workforce capable of delivering results consistent with corporate goals and objectives.
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Provide after hour support for various manufacturing events.
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Other Duties and Responsibilities
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Complete other duties as assigned.
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Education, Experience, and Qualifications
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High School plus 2 years vocational / technical school certification or equivalent in the areas of electrical, electronic, or Electro-mechanical technologies
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5 years of production equipment maintenance
Knowledge of refrigeration operations is preferred, but not required.
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Knowledge of and demonstrated skill in working on basic electrical, mechanical, plumbing, and machining operations is preferred.
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Strong multi-tasking capabilities
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Flexibility and willingness to adapt to a changing environment and work load
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Knowledge of and demonstrated skill in basic Programmable Logic Control (PLC) system operations
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Knowledge of and demonstrated skill in basic equipment control system operations
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Demonstrated problem solving ability such as the ability to diagnose problems by separating essential from non-essential variables
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Knowledge of and basic skill in using Microsoft Word and Excel. Familiarity with Google Suite
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Knowledge of a Capital Expenditure Request process such as writing the justification for the purchase of a new piece of equipment
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Excellent written and verbal communications
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Ability to work and communicate effectively with a wide range of co-workers in a cooperative manner
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Ability to work with minimal supervision
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Knowledge of GMP and ISO regulations desired
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Working Conditions
Physical Demands, Travel, etc.
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Exposure to biohazardous material.
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May spend long periods of standing or sitting.
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Must wear appropriate PPE depending on the environment the technician may be in.
- Potential for travel for off-site equipment training.
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This description is intended to be only a general outline of job activities. An employee is expected to perform these and any other activities which may be assigned or which may occur during work. This description is not a contract or guarantee of employment.
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