Facilities Maintenance Professional
The successful candidate will be responsible for ensuring the smooth operation of our manufacturing facility, maintaining quality systems and providing support to new equipment installations and product introductions.
Key Responsibilities:
* Proactively ensure that all EHS responsibilities are carried out according to regulations and procedures.
* Provide support to new equipment installations and product introductions.
* Maintain the Maintenance Quality System by adherence to all relevant SOPs, policies and cGMP requirements.
* Plan and coordinate scheduled and unscheduled maintenance tasks in accordance with site policies and procedures.
* Maintain spare parts, change parts and equipment both within the DS facility and in the Engineering Stores.
* Ensure the Maintenance Management System is maintained correctly.
* Utilise and maintain IT systems as required e.g. Computerised Calibration Systems and Computerised Maintenance Management Systems.
* Lead shift-handovers and report issues using a Tier-meeting approach.
* Provide support to Operations Validation Engineering and Quality where required.
Requirements:
* Associate Degree &/or certification in a mech elec or related field is required.
* 3-5 years experience in an appropriate cGMP commercial manufacturing environment preferably with experience on upstream cell culture and downstream purification.
* Prior hands-on experience with CMMS and Computerised Calibration Systems.
* Prior experience with Quality Management Systems.
* High level of interpersonal communication and technical problem-solving skills.
* Demonstrable knowledge of cGMP for process equipment instruments 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.