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As a Technician, Engineering Senior - you will conduct preventative maintenance, calibration and repair of electro-mechanical systems, various types of production equipment, electrical, pneumatic systems resulting in minimal downtime and operational costs to the company. You will also provide support for, or conduct, validation activities and provides training on validated systems. Provide ongoing support of the manufacturing processes and personnel. Identify potential process improvements and implement processes. Provide on-call support for and response to after hour emergencies and alarms.
Job Responsibility:
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
Investigate equipment operational issues in order to prevent recurrence. Update equipment schedules (PM) and/or design where appropriate
Provides appropriate communication as to progress of critical repairs
Assists in maintaining appropriate spare parts and inventory levels
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
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
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
Participate in training and educational endeavors designed to develop a highly skilled workforce capable of delivering results consistent with corporate goals and objectives
Conduct training and serve as a mentor to the Engineering Technician role
Assist the Principal Engineer to set priorities and direct activities of the Engineering Technician
Provide after hour support for various manufacturing events
Requirements:
High School Diploma or equivalent required
2 years vocational / technical school certification or equivalent in the areas of electrical, electronic, or Electro-mechanical technologies required
10+ years of production equipment maintenance
Knowledge of and demonstrated skill in working on basic electrical, mechanical, plumbing, refrigeration, and machining operations
Strong multi-tasking capabilities
Flexibility and willingness to adapt to a changing environment and work load
Knowledge of and demonstrated skill in basic Programmable Logic Control (PLC) system operations
Knowledge of and demonstrated skill in basic equipment control system operations
Demonstrated problem solving ability such as the ability to diagnose problems by separating essential from non-essential variables
Knowledge of and basic skill in using Microsoft Word and Excel. Familiarity with Google Suite
Knowledge of a Capital Expenditure Request process such as writing the justification for the purchase of a new piece of equipment
Excellent written and verbal communications
Ability to work and communicate effectively with a wide range of co-workers in a cooperative manner
Ability to work with minimal supervision
Nice to have:
Knowledge of GMP and ISO regulations desired
What we offer:
comprehensive plan of health benefits
retirement and financial wellbeing
time off programs
wellbeing support and perks
may be eligible to participate in an annual incentive program