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Details
CQV Engineer (Remote)
Reference: | /RH/151021 | Location: |
Dublin |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Permanent | Salary: | 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.
- 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]
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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