Equipment Engineer

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Equipment Engineer
role at
PM Group
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Equipment Engineer
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PM Group
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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:
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
Seniority level
Seniority level
Not Applicable
Employment type
Employment type
Full-time
Job function
Industries
Construction and Design Services
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