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Computer System Validation Specialist

Experience Dependent
Job Reference: J5633697
Updated On: 27/08/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Contract Manufacturing Organisation, Life Sciences

Skills: Engineering - Chemical / Process, Engineering - Projects, Engineering - Systems, Validation - Process Validation, Validation - Equipment Validation, Validation - Cleaning Validation, Validation - Facilities/Utilities Validation

Job Information

Role Overview

Are you an experienced Computer System Validation Specialist looking for a new exciting job opportunity?

We are currently looking for a CSV Specialist to join a leading pharmaceutical company based in the Wiltshire area.

As the CSV Specialist you will be responsible for managing and executing validation activities associated with the cGMP compliance of computerised and software systems, ensuring that they are appropriately qualified for fit for operational use.

Key Duties and Responsibilities

Your duties as the CSV Specialist will be varied however the key duties and responsibilities are as follows:

1. As the CSV Specialist you will balance multiple project-based activities, coordinating the generation, review and execution of validation protocols with the relevant stake-holders. In addition, you will have an input into CAPEX projects where there is a significant computerised / software content, ensuring that systems have been appropriately designed and qualified to ensure effective and cGMP compliant operational use.

2. You will write, review and finalize validation documentation for new and existing laboratory equipment and computerised systems in the GxP environment. You will also be responsible for approving validation documentation including protocols and reports, and manage the timely closure of any discrepancies or non-conformities.

3. You will be responsible for maintaining the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities.

4. The CSV Specialist will interact with internal and external suppliers in function of design, validation, implementation, maintenance and calibration of systems.

Role Requirements

To be successful in your application to this exciting opportunity as the CSV Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in a relevant field of science, engineering or IT. You will also need to have substantial industry experience of generation, execution and review of validation protocols, reports and technical documents.

2. Proven industry experience of working within a GMP quality system and technical understanding of computerised systems including PLCs, SCADA, networked systems, laboratory systems, databases and layered software as used in a GxP environment is essential.

3. Experience of working with product serialisation qualification and a comprehensive understanding of EU and FDA regulatory requirements relating to validation including UK/EU GMP Annex 11 and 21 CFR Part11 would be highly desirable.
Debra Fong
Your Recruitment ConsultantDebra
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.