Our client work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.
• Schedule, monitor and verify the PM, instrument calibration and environmental re-qualification activities.
• Participate in preparation, execution and review of qualification and engineering tests/protocols (URS,DQ,FAT, IQ,OQ,PQ).
• Monitor and verify routine readings and ensure compliance as per requirements and follow up on issues raised.
• Follow and ensure staff and contractor entry and exit into production, stores, laboratory areas are as per procedure.
• Review and close tasks and breakdown event sheets and ensure a robust spare parts inventory.
• Address deviations /incidents during breakdown/PM/Risk Assessments/IPQ.
• Ensure checks are carried out for respective areas and review PM schedules records for building maintenance activities.
• Manage the maintenance technicians performance on an ongoing basis to include documented performance reviews, IDP’s. Conduct SOP related training and ensure that the appropriate standards of GMP are maintained at all times.
• Ensure selection and usage of proper PPE for respective areas. Adhere to all company & legislative EHS requirements. Support and implement all Global EHS programs and initiatives.
• Minimum of a Bachelor's Engineering Degree and 4+ years’ experience in an engineering role preferably within the pharmaceutical/ medical device industry. However, a combination of experience and/or education will be taken into consideration.
• Experience of FDA, HPRA audits an advantage.
• Experience of working in a highly regulated cGMP environment.
• Ability to provide leadership, develop and training of team members.
• Excellent analytical and problem-solving skills.
• Strong organizational, interpersonal skills. the ability to effectively communicate with peers.
• Ability to respond quickly to a changing production environment.
• Structure skills to create and execute a preventative maintenance program that ensure plant and equipment reliability.
• Accuracy and attention to detail.
• Ability to work cross functionally with all other department.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287