We are seeking a CQV Engineer to join our clients expanding Life Sciences division. This is a staff consultancy role based in Dublin, with the first project located on-site in Co. Louth.
Overview
You will collaborate with our high-performance team of Technical Engineers, working within an expanding group to deliver cutting-edge solutions for clients. Your key responsibilities include scoping, planning, implementing and refining solutions tailored to client requirements.
Key Responsibilities
* Conception, planning and execution of Commission, Qualification and Validation (CQV) activities in regulated environments, including Pharma, Medical Devices and Biotech.
* Collaboration with clients to perform gap analysis and early engagement assessments, ensuring thorough understanding of required scope for full assessments.
* CSV Assessments and Health Checks to evaluate compliance, with clear reporting to senior stakeholders on findings and recommended solutions.
* Resolution of fundamental Computer System Validation (CSV) compliance issues arising from implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems.
* Maintenance of accurate records of project-related issues and deviations, ensuring timely documentation and approval.
* Verification that computer system validation activities comply with internal procedures and external regulations and standards.
* Review and approval of documents prepared by project teams, other departments and contractor organizations.
Qualifications and Experience
* Relevant third-level qualification or equivalent work experience.
* A minimum of 3-5 years' experience in Validation, specifically CSV or CQV.
* Prior experience working with laboratory systems.
* Development and review of validation documentation, including Validation Plans, IQ, OQ, PQ, RTM and Reporting.
* A strong emphasis on openness and transparency.