Kenny-Whelan & Associates ,
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Project Engineer - 2 Years
JO-1206-248280
validation project management DOE npi qualification
Cork Munster
55000 - 65000
5 - 6 Years
Temporary Full-time
Third Level Degree
Linda Nugent
lnugent@kenny-whelan.ie
Project Engineer - 2 Years
In partnership with its client, Kenny-Whelan is currently seeking a Project Engineer to work for their client in the Cork area. This role reports to the Process and Technology Manager, you will be responsible for a conversion project to defined schedule.
Job Responsibilities:
· Define design of experiment (DOE) requirements for inclusion in qualifications for each product line. · Manage operational and validation preparation for execution of qualification activities including documentation, raw material, equipment and resource requirements. · Review and approve qualification protocols and reports for the project. · Drive execution and documentation of qualification runs according to the schedule and communicate schedule changes as they arise. · Report on progress to site management and the core implementation team. · Oversee shipping of qualification material to further processing plants. · Investigate non conformances, differences or defects for qualified material and perform root cause analysis as required. · Implement and operate systems to maintain traceability of qualified material. · Build relationships with device plant teams and Core implementation team to develop cross site communication on the change. · Liaise with product managers and define strategy and timelines for customer notification. · Co-ordinate samples for laboratory testing and customer testing as required for each qualification protocol executed. · Manage operational readiness activities to changeover to new material on schedule. · Work with the planning team to identify and execute changeover in line with product demand.
Skills, Abilities and Education
· Degree in Chemistry/Chemical/Process Engineering or equivalent. · Experience: 5+ years relevant experience, preferably within the Chemical Process, Pharma or Medical Device Industry. · Excellent engineering/science/technical ability · Project management skills · Strong organisational ability · Self motivation and drive · Communication- strong written, oral and presentational skills. · Strong leadership & facilitation skills
Kenny-Whelan Contact:
If you are interested in the above role, please send an updated CV marked for the attention of Linda Nugent, email: lnugent@kenny-whelan.ie or telephone for a confidential chat on 021-4665407
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