Summary: Our client is a pharmaceutical company based in East Cork, looking for a Maintenance Technician to join their team.
The successful candidate will be responsible for setup, planned maintenance and fault finding of automated Vial, Bottle& Blister packaging equipment, automated inspection, and serialization equipment.
Responsibilities: Responsible for scheduled maintenance of packaging equipment and documenting works to a GMP standard.
Manage external contractors when required during equipment installations and planned service visits.
Manage spare parts, consumables, and services to keep equipment schedules compliant.
Develop, Implement, and promote a Reliability Centered Maintenance (RCM) strategy using Failure Mode Effects and Criticality Analysis (FMECA/FMEA) assessments in conjunction with Packaging Team and operations, utilizing tools such as Trends analysis & Control charts & Data review.
Support the creation and modification of documentation to support maintenance and calibration activities (PM, Data Sheets, Work Instructions, troubleshooting guides).
Support compliance efforts related to Safety Events, Quality Events, CAPAs, change management and investigations and assist in the investigation and resolution of electrical and mechanical issues on equipment.
Ensure maintenance routines, procedures, and work plans are developed to the necessary standards and best practice to ensure compliance with GMP and EHS regulations.
Comply with GMP & EHS requirements from a local, global, and regulatory perspective.
Support Project FAT'S, SAT'S, testing and qualification.
Qualifications & Experience: Minimum of a Certification in Electrical/Mechanical Engineering and a minimum of 5 years relevant experience.
However, a combination of experience and education will be taken into consideration.
Must have a thorough working knowledge within a cGMP regulated environment, FDA, HPRA environment.
Familiar with Maintenance management systems, Utility systems, Packaging equipment, PLC's.
Computer literacy (Word, Excel, PM systems).
Report preparation & presentation.
Ability to manage multiple projects and activities simultaneously.
Skills: Computer literacy Packaging equipment Report preparation Multitasking cGMP