Overview

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.

 

 EDUCATION:

 

  • 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.

 

 

Skills:

  • 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

 

 COMPUTER/IT SKILLS:

  • Highly proficient in MS Office, CMMS

All applications will be treated with the strictest confidence

Kenny-Whelan Contact:

For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or send your updated CV to [email protected]