Dolmen Engineering currently has a requirement for a Senior Packaging Maintenance Technician for our client site in Galway.
The Senior Packaging Maintenance Technician will be responsible for scheduled maintenance of packaging equipment and documenting works to a GMP standard.
Key responsibilities for this role include:
- Responsible for Setup, planned maintenance and fault finding of automated Vial and Syringe packaging equipment, automated inspection, and serialization equipment.
- 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.
- 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.
The minimum qualifications for this role are:
- 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.
- Excellent Interpersonal, communication skills, conflict management, negotiation and structured decision making.
- Good computer literacy (Word, Excel, PM systems) and Report preparation & presentation.
- Ability to manage multiple projects and activities simultaneously.
- Proven analytical and problem-solving skill.
- Ability to build effective working relationships.