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Overview
The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.
We are looking for an experienced Equipment Engineer ro work on a Client site in Cork. The Equipment Engineer will be responsible for managing project deliverables and equipment qualification through technology transfer and commercialization in a new manufacturing facility.
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. Identify, support or direct the execution of improvement efforts to reduce waste, increase yields and improve product quality in the manufacturing area
* Identify and develop risk-based approach to change management in conjunction with validation and QA groups
* Support the more junior engineers in the development of URS documents, interactions with key equipment vendors, and execution of effective commissioning and qualification protocols
* Ensure that accurate and representative equipment performance data is generated, gathered, analysed and trended
* Deliver regular reporting of equipment performance and provide technical support to sustaining manufacture operations
* Apply and lead DMAIC - Six Sigma approaches to solve issues and reduce variation in all manufacturing areas
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)
* Experience and knowledge in the following areas is an advantage:
o Execution Of C&Q activities (FATS, IOQs, Commissioning)
o P&ID and Electrical Schematics
o Lock-Out Tag-Out of equipment
o CE Marking process and terminology
o Procurement activities - creating purchase requisitions, tracking invoices, receipt verification
o Creating/updating/reviewing equipment related SOPs
o Project scheduling tools - e.g. MS Project, Primavera P6, etc.
o Calibration of Equipment
o Preventative Maintenance
o Enterprise Resource Planning (ERP) Systems (e.g. SAP)
o QMS documentation systems and knowledge of cGMP
o Managing and coordinating small teams of people
o Knowledge of regulations and applicable standards in Life Science industry
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Industries
Construction and Design Services
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