Senior Manufacturing Engineer

EPM Scientific; Cork; On-site; EUR 55,000 - 83,000; Full time

Job summary

EPM Scientific are supporting a large MedTech in Cork to hire a Sr. Manufacturing Engineer on a 12 month contract.

The role focuses on equipment and line moves as part of a spatial optimisation project and is an hourly rate contract on site in Cork, 40 hours per week. The successful candidate will develop a world-class manufacturing group, lead CIP improvements, transfer processes from development or other facilities, and ensure GMP-compliant documentation and process validation activities

Qualifications

• Experience with Six-Sigma tools and methods.
• Strong GMP knowledge and documentation practices.
• Experience with equipment validation (IQ/OQ/PQ) and process transfers.

Responsibilities

• Assist in building a world-class manufacturing group focused on process improvement and problem solving using Six-Sigma tools.
• Monitor line performance and develop/execute structured event plans to remediate sub-optimal performance.
• Develop and implement supporting documentation, SOPs and work instructions compliant with GMP.

Skills

Validation

Equipment Qualification

Medical Devices

GMP

Job description

EPM Scientific are supporting a large MedTech based in Cork to hire a Sr. Manufacturing Engineer on a 12 month contract, supporting primarily with Equipment & Line moves as part of a spacial optimisation project.

This is an hourly rate contract, starting ASAP on site in Cork, working 40 hours per week.

• Responsible for assisting in the development of a world class-manufacturing group that is proficient in process improvement and problem solving manufacturing issues using Six-Sigma tools.
• Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
• Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP)
• Leading technical improvements under the business's Continuous Improvement Program (CIP).
• Transferring and implementing processes, either from development, or from another manufacturing facility.
• Provision of technical leadership/guidance for the Process / maintenance Technicians and other Manufacturing / Equipment Engineers on the team.
• Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented in accordance with New product Development Processes.
• Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
• Conduct Gauge R&R studies for products and new processes.
• Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets their training is documented.
• Continuous monitoring and reporting of variables that feed into the business performance metrics, and pro-active identification and resolution of issues around any deficits in same.
• Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site
• Elimination and/or management of material risks on the production floor in cooperation with Supplier Quality engineers
• Undertaking, where appropriate, a Subject Matter Expert's role for Regulatory Audit purposes
• Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
• All other duties as assigned.
  

EPM Scientific are supporting a large MedTech based in Cork to hire a Sr. Manufacturing Engineer on a 12 month contract, supporting primarily with Equipment & Line moves as part of a spacial optimisation project.

This is an hourly rate contract, starting ASAP on site in Cork, working 40 hours per week.

Job description:

• Responsible for assisting in the development of a world class-manufacturing group that is proficient in process improvement and problem solving manufacturing issues using Six-Sigma tools.
• Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
• Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP)
• Leading technical improvements under the business's Continuous Improvement Program (CIP).
• Transferring and implementing processes, either from development, or from another manufacturing facility.
• Provision of technical leadership/guidance for the Process / maintenance Technicians and other Manufacturing / Equipment Engineers on the team.
• Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented in accordance with New product Development Processes.
• Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
• Conduct Gauge R&R studies for products and new processes.
• Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets their training is documented.
• Continuous monitoring and reporting of variables that feed into the business performance metrics, and pro-active identification and resolution of issues around any deficits in same.
• Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site
• Elimination and/or management of material risks on the production floor in cooperation with Supplier Quality engineers
• Undertaking, where appropriate, a Subject Matter Expert's role for Regulatory Audit purposes
• Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
• All other duties as assigned.
  

Desired Skills and Experience

• Validation, Equipment Qualification, Medical Devices, GMP