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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Validation Engineer


Reference:/RH /8817 Location: Cork
Munster
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, Validation Coordinator, Validation Engineer, Validation Scientist, Validation Specialist

Staff Validation Engineer required for a international engineering company.


Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Responsible for preparing and executing commissioning, qualification, and validation for new products, processes, equipment and industrial software as well as assisting in maintaining them in a validated state.
  • Supports validation activities in a GMP regulated manufacturing environment. The Validation engineers will prepare, review, and execute commissioning, qualification (IQ, OQ, PQ), and validation (PV and CV) documents for products, facilities, processes, software and equipment.
  • Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations.
  • Aids in the planning of commissioning, qualification and validation activities and in interfacing with QA, Production Operators, and Engineering
  • Ability to handle multiple commissioning, qualification, validation priorities based on the needs of the manufacturing area with guidance from management.

Education and Experience:
  • Bachelor’s degree in Engineering or related field, or equivalent combination of education and work-related experience, required.
  • Minimum 3-5 years Qualification (IQ, OQ, PQ) / Validation (PV, CV), GXP experience.
  • Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
  • Demonstrated troubleshooting and problem solving skills including the use of designed experiments.
  • Ability to handle multiple tasks/projects
  • Good influencing and negotiation skills to accomplish the same goals for internal and external stakeholders according to Project and business need.
  • Understanding engineering disciplines, work package management and work package control.

For more information contact Ruth Holland on 087 7822 198 or [email protected]