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CSV Validation Engineer

WaterfordContract
Experience Dependent
Job Reference: J5635948
Updated On: 26/04/2022
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Software, IS&T, Technology

Skills: Quality Assurance - Contract, Quality Assurance - GMP, Quality Assurance - Validation, Quality Assurance - CSV, IT Pharma - Operations - LIMS, IT Pharma - Software - GxP

Job Information

Role Overview

We are currently looking for a CSV Validation Engineer to join a leading Pharmaceutical company based in the Waterford area on a hybrid solution. As the CSV Validation Engineer you will be responsible for

Key Duties and Responsibilities

1. The CSV Validation Engineer will be expected to have a depth knowledge of the requirements for Computerised Systems and supporting system design.
2. Full interpretation of GAMP 5, EU GMP Annex 11 - EudraLex Volume 4 - EU guidelines to Good Manufacturing Practice –
3. Products for Human and Veterinary Use, Annex 11: Computerised Systems. [21 CFR Part 11]
4. Food and Drug Administration Code of Federal Regulations - Electronic Records, Electronic Signatures, Final Rule. General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

Role Requirements

1. A minimum of a Bachelors Degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech).
2. Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
3. Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
Nathan Pepperall
Your Recruitment ConsultantNathan Pepperallnathan.pepperall@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.