The Equipment Engineer role is a critical position in our team, responsible for managing project deliverables and equipment qualification through technology transfer and commercialization in a new manufacturing facility.
Key Responsibilities
* Develop a deep understanding of the Manufacturing and Laboratory equipment being purchased and installed as part of the project.
* Plan, coordinate and execute onsite validation activities - Installation Qualification (IQ) and Operational Qualification (OQ).
* Work closely with cross functional teams in monitoring project performance.
* Provide weekly status updates on progress, highlight issues as well as suggesting solutions.
* Support all company safety and quality programs and initiatives.
* Ensure compliance with cGMP and safety rules on new and existing equipment.
* Support production equipment transfer, taking a hands-on lead role in activities required to achieve commercialization.
* Provide engineering inputs to the design / URSs for process equipment.
* Support the training of engineers and production personnel.
* Project manage / coordinate key projects and the project workstream within the areas of assigned responsibility.
* Support the continuous improvement strategy in conjunction with the Manufacturing, Quality and Engineering functions in the area.
Qualifications
* The successful candidate will have a qualification in Chemical / Process / Mechanical / Automation Engineering or similar Third level Qualification.
* Minimum 5-8 years experience in medical device or similar industry with an established track record.
* Strong candidates coming from an automotive / semiconductor / electronics or other GMP / FDA regulated background will also be considered.
Benefits
This role offers the opportunity to gain unrivalled experience working with global brands and to work on a Client site in Cork.
Requirements
* Execution Of C&Q activities (FATS, IOQs, Commissioning)
* P&ID and Electrical Schematics
* Lock-Out Tag-Out of equipment
* CE Marking process and terminology
* Procurement activities - creating purchase requisitions, tracking invoices, receipt verification
* Creating/updating/reviewing equipment related SOPs
* Project scheduling tools - e.g. MS Project, Primavera P6, etc.
* Calibration of Equipment
* Preventative Maintenance
* Enterprise Resource Planning (ERP) Systems - e.g. SAP
* QMS documentation systems and knowledge of cGMP
* Managing and coordinating small teams of people
* Knowledge of regulations and applicable standards in Life Science industry