Maintenance Area Support Specialist
4 settimane fa
Job Summary:
We are seeking a highly skilled Maintenance Area Support professional to join our team at Thermo Fisher Scientific. As a key member of our maintenance team, you will be responsible for ensuring the smooth operation of our production equipment, improving performance, and reducing downtime while adhering to budget constraints, production needs, quality standards (cGMP-cFDA), and company procedures.
Key Responsibilities:Preventive Maintenance- Identify opportunities for process improvements and maintenance procedures, including detailed checklists and spare parts requirements.
- Provide technical assistance for maintenance and urgent interventions during critical phases, leveraging acquired technical knowledge through preventive maintenance analysis.
- Communicate anomalies and equipment status to the entire organization, participating in technical discussions on potential improvement opportunities and identifying modifications and improvements.
- Analyze historical trends for equipment types and share a clear Pareto chart with actions to mitigate recurrence with your supervisor.
- Monitor and provide technical support, as needed, for new installations or modifications to all departmental equipment, updating spare parts inventory and acquiring familiarity with new preventive maintenance techniques introduced.
- Collaborate in standardizing and drafting requirements for new equipment. You will acquire in-depth knowledge of new equipment and tools during FAT, SAT, and on-site qualification phases, including learning about operational characteristics, maintenance, and problem-solving related to machines, as well as the ability to guide and assist technical personnel during these processes.
- Work collaboratively with suppliers and colleagues to optimize the plant's inventory, ensuring continuous communication with them to capture opportunities to maintain or improve equipment status.
- Ensure adequate support for the responsible person in preparing the area budget and provide assistance in managing and controlling costs, reporting any variations or inefficiencies.
- Contribute to the revision of standard operating procedures (SOPs) related to maintenance, in accordance with company quality policies and superior directives.
- Ensure adherence to company quality standards by closely monitoring the application of maintenance procedures, reporting any irregularities, and promoting improvement initiatives to ensure the highest possible quality of products and services.
- Ensure correct reporting and opening of deviations and changes (in accordance with existing change control and deviation procedures) that are necessary or have been identified on equipment and GMP machinery.
- Collaborate in case of investigations on production machinery, providing information and evidence from the maintenance status of the machines.
- Refer to Article 20 of 81/08 and - Obligations of the worker.
All employees are responsible for their own health and safety and that of others due to the actions they perform and the associated risks, as well as the environmental protection of their workplace and every space in the Plant, in accordance with the provisions in this regard dictated by the Company.
Internal and External Relationships:
- All company functions
- Specialized suppliers / contractors
Requirements and Qualifications:
(a) Essential:
Studies/Diplomas/Courses:
- Engineering / Technical Diploma or experience
Technical and Informatics Knowledge:
- Deep knowledge of pharmaceutical machinery
- Knowledge of the methods used and interventions in sterile environments
- GMP, Safety, Office
Professional Experience:
- Management of complex equipment and plants with high risks
Languages:
- English
Personality Traits:
- Availability/flexibility of schedule
- Intuition
- Ability to motivate a team of workers
(b) Desirable:
- Knowledge of TPM and the methodologies used
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