- Reference: 43759
- Job Type: Permanent
- Location: Kildare, Offaly, Westmeath
- Category: Engineering, Technical & Manufacturing
- Assist with the implementation of a new PEMAC CMMS including setting up of routines and assets, spares etc. Ensure all assets are registered on the system and there are routines in place for them. Put in place system for generation and distribution of work orders and follow up for completion.
- Assist with setting up the PEMAC helpdesk and put procedures in place to ensure management of tasks generated from this system.
- Assist with setting up PEMAC care system for risk assessments and carry out risk assessments of various facilities and utility systems. Follow up with other departments to ensure all risk assessments are carried out correctly and on time.
- Day to day operation and maintenance of all utilities and systems necessary to support manufacturing
- Assist in the temperature mapping and validation of various plant items including, fridges, incubators, cold rooms and autoclaves. Prepare protocols as necessary for this work to be completed.
- Preparation of SOP’s and forms to ensure the engineering dept. is GMP compliant with regard to documentation.
- Operation and maintenance of the onsite plant monitoring system. Assist with the upgrade of this system and preparation of new SOP’s
- Participate in Quality and Safety regulatory audits as required
- Assist with calibration of instrumentation on plant equipment and utilities and preparation of SOP’s for all items.
- Liaise with production, QA and outside vendors to schedule validation and calibration work on equipment and utilities
- General maintenance duties as arising on site
- Participate in Engineering Department or cross –functional projects
- Management of contractors on site to carry out work
- Adhere to safe working practices as set out in the safety statement and other safety instructions. Also assist in providing a safe place of work for employees
- Setting up and carrying out of environmental tasks required for compliance with Bionua IPC licence. Preparation of Environmental SOPs as required.
- Manage changes to systems through the change control procedures on site.
- Other duties as assigned by the Engineering Manager.
Qualification and Experience:
- Degree/Diploma/Apprenticeship in relevant Engineering discipline.
- 3-5 years’ experience in pharmaceutical/healthcare industry.
- Experience of managing a CMMS system (Implementation of CCMS desirable)
- Excellent interpersonal and communication skills.
- Knowledge and experience in calibration and validation of utilities and equipment including fridges, freezers, incubators and autoclaves.
- Ability to prioritise, plan and manage tasks to meet agreed deadlines.
- Excellent verbal and written communication skills. Ability to maintain very clear records of work completed
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