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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

CQV Engineer (Remote)


Reference:/RH/151021 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Validation Engineer, Validation Specialist

CQV engineer required for a staff roles with an engineering consultanty firm. The first project is fully remote.

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.

Role & 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 solutions
  • Resolution of fundamental Computer System Validation (CSV) compliance issues derived from implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems
  • 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
  • Assist in development of validation strategy and validation plan for computer system validations.
  • Assist with change control activities in accordance with site procedures
  • Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with system changes and new technology development.
Qualifications & Requirements:
  • 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
  • Client-facing skills
  • People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
  • Team work and emotional intelligence
  • Good self-management – continuous performance is both an objective and a mind-set
  • Has an innovative approach – a bold thinker and doer, matching creativity with vigilance

For more information contactRuth Holland on087 7822 [email protected]