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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

CQV/Validation Engineer


Reference:/RH/24112203 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, Validation Specialist

We are hiring for a CQV Engineer (staff consultancy role) to join our clients expanding Life Sciences division. The client's HQ is based in Dublin, and the first project is based on site in Co. Louth.

Overview:
You will join our high-performance team of Technical Engineers and work within an expanding team providing cutting-edge solutions to clients. You will work collaboratively with our customers to scope, plan, implement and refine solutions specific to client requirements.


Responsibilities

  • Conception, planning and performing of Commission, Qualification and Validation (CQV) in the regulated environment (Pharma, Medical Devices, Biotech).
  • Work directly with our clients to perform gap analysis / early engagement assessments to understand the required scope of full assessments.
  • Conduct CSV Assessments / Health Checks to assess compliance and report back to senior stakeholders with findings and suggested solution.
  • Resolution of fundamental Computer System Validation (CSV) compliance issues derived from implementation of 21 CFR Part 11 automated controls/functionalities in legacy system
  • Ensure all project related issues and deviations are documented and approved
  • Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards
  • Review and approve documents prepared by project teams, other departments and contractor organizations

Qualifications and Experience:
  • Relevant third level qualification or equivalent work experience
  • 3-5 years’ Validation experience (CSV or CQV)
  • Experience with lab systems
  • Development and review of validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Reporting)
  • High value on openness and transparency.


Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required.
No visa sponsorship will be offered with this role.

Call Ruth Holland on 087 7822 198 for more details.