Process Maintenance Technician
In partnership with its client Kenny-Whelan & Associates is currently seeking a Process Maintenance Technician for the Athlone area.
Profile of Role:
The Process Maintenance Technician is responsible for the Maintenance, Repair, Trouble-shooting and Replacement of all production equipment on site.
This position is also responsible for assisting in the co-ordination and scheduling of maintenance works performed by service vendors in both the Biologics and Fill Finish Environment.
DUTIES & RESPONSIBILITIES:
- Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
- Provide support to new equipment installations and product introductions
- Perform scheduled and unscheduled maintenance tasks in accordance with site policies and procedures.
- Responding to equipment breakdowns in a timely manner.
Maintaining spare parts, change parts and equipment both within Manufacturing Areas and in the Engineering Stores.
- Ensure the Maintenance Management System is maintained correctly.
- Utilising and maintaining IT systems as required, e.g. Computerized Calibration Systems and Computerized Maintenance Management Systems.
- Act as a subject matter expert for the Facilities and Maintenance group in relevant equipment and system root cause investigations and fill the role of lead investigator where required.
- Maintaining the Maintenance Quality System by adherence to all relevant SOP’s, policies and cGMP requirements.
- Assist in writing and revising of Maintenance Standard Operating Procedures as required.
- Filing and archiving of Facilities and Maintenance documentation.
- Provide support to Operations, Validation, Engineering and Quality where required.
- Complete training with new/junior Maintenance Technicians
- Provide on-call support during operation, project and shutdown activities, as required.
- Associate Degree and/or technical certification in a Mechanical, Electrical or related field is required.
- 5+ years experience performing facilities and maintenance support activities in a cGMP commercial manufacturing environment, preferably with experience on some or all of the following: Downstream Processing (Ultra or Dia-filration), Vial Filling Equipment (Isolator or RABs technology)
- Prior hands-on experience with CMMS and Computerized Calibration Systems
- Prior experience with Quality Management Systems.
- Good interpersonal, communication and problem-solving skills
- Must be knowledgeable of the regulatory and GMP requirements for process equipment, instrumentation and calibration
- Knowledge of Sigma and Lean systems is an advantage.
- Ability to make informed and timely decisions that take into account the facts, goals, constraints, and risks associated.
- A Team Player with a ‘can do’ proactive attitude and a passion for improvement
- Highly proficient in MS Office, CMMS
All applications will be treated with the strictest confidence
For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or send your updated CV to [email protected]