Dolmen Engineering currently has a requirement for a Packaging Technician for our client site in Galway. The Packaging Technician is responsible for the maintenance of packaging, inspection, and equipment serialization.
Roles & Responsibilities:
- Setup, planned maintenance and fault finding of automated Vial and Syringe packaging equipment, automated inspection and serialization equipment.
- Carry out scheduled maintenance on equipment and responsible for documenting works to GMP standard.
- Manage external contractors when required during equipment installations and planned service visits.
- Plan spare parts, consumables and services to keep equipment schedules compliant.
- Develop, Implement, and promote a Reliability Centred Maintenance (RCM) strategy using Failure Mode Effects and Criticality Analysis (FMECA/FMEA) assessments in conjunction with Packaging Team and operations. Utilising tools such as Trend’s analysis & Control charts & Data review.
- Support the creation and modification of documentation to support maintenance and calibration activities (PM, Job Plans, 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 all GMP & EHS requirements and compliance both from a local, global and regulatory perspective.
- You will be required to be flexible in this position and must be prepared to such undertake overtime, shift changes and callout duties and other works as may be assigned to your role by the company.
- Minimum of a Certification in Electrical/Mechanical Engineering and a minimum of 2 years relevant experience. However, a combination of experience and education will be taken into consideration.
Essential Experience & Role Requirements:
- 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.