Are you an innovative, solution focused, resilient and motivated individual? This is the role for you!
In this role, the successful candidate will conduct assignments encompassing complete projects or portions of major projects. This will involve determining the methods and techniques to be used or adapt standard methods to meet variations.
Major Responsibilities & Duties:
Some of the major responsibilities and duties will fall under the following headings.
*New Product/Process Introduction
*Product Quality, Control & Disposition and Performance Standards
*Production/Process Controls including Control Plans
*A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience.
*Experience working in both an FDA and European regulatory environment is preferred.
*This position will require relevant experience working in manufacturing/operations.
*In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
*Experience with a proven track record of implementing appropriate risk mitigation.
*Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
*Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
*The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
*Good technical understanding of manufacturing equipment and processes is required.
*Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
*A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
*Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
*Demonstrated project management and project leadership abilities are preferred.
Please note: this position may require up to 10% travel and will be based in an MD&D manufacturing facility.
Please get in touch if you would like to learn more about this opportunity.
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.