Manufacturing Engineer

Overview

Currently seeking a Sr.

Manufacturing Engineer to join a Medical Device client to support the Qualification of a Cleaning & Sterilisation Process onto their site.

This is an ASAP start, full time and long-term hourly rate contract, primarily on site in East Cork.

Ideal candidates possess a strong experience in Medical Device Engineering roles.

Validation expertise is essential (IQ / OQ, EQ, PQ, MSA), with a preference for candidates with experience with Cleaning & Sterilisation.

Responsibilities

Responsible for assisting process improvement and problem-solving manufacturing issues using Six-Sigma tools.

Providing technical leadership on all product and process issues.

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\' Continuous Improvement Program (CIP).

Transferring and implementing processes, either from development, or from another manufacturing facility.

Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented according to New product Development Process.

Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.

Conduct Gauge R&R studies for products and new processes.

Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate.

Observing the Quality Management Systems requirements on site at all times.

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 co-operation with Supplier Quality engineers.

Qualifications

Validation experience is essential (IQ / OQ, EQ, PQ, MSA), with a preference for candidates with experience in Cleaning & Sterilisation.

Desired skills include IQ, OQ, PQ, Sterilisation, Cleaning, MSA, and Equipment Qualification.

#J-18808-Ljbffr