validation project management DOE npi qualification
55000 - 65000
5 - 6 Years
Third Level Degree
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.
· 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
If you are interested in the above role, please send an updated CV marked for the attention of Linda Nugent, email: firstname.lastname@example.org or telephone for a confidential chat on 021-4665407