12 Month Contract
The Biologics Process Maintenance Technician is responsible for the maintenance, repair, troubleshooting and replacement of all production equipment. The main location for this role is within the Biologics Facility. 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.
The individual in this position is expected to represent my client's interests, objectives and policies in a professional and responsible manner. Daily duties will be guided by the Manufacturing Engineer in the area. The successful candidate will report overall into the Snr. Manager for Manufacturing Engineering and the role will offer scope for both personal and career development.
The main responsibilities will be as follows:
· 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.
· Maintaining the Maintenance Quality System by adherence to all relevant SOP's, policies and cGMP requirements.
· 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. Computerised Calibration Systems and Computerised 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.
· Assist in writing and revising 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 Six 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, pro-active attitude and a passion for improvement.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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