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Validation Specialist

Experience Dependent
Job Reference: J5635128
Updated On: 18/06/2021
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Life Sciences, Diagnostics

Skills: Engineering - Validation Perm, Validation - Process Validation, Validation - Equipment Validation, Validation - Cleaning Validation, Validation - Facilities/Utilities Validation

Job Information

Role Overview

We are currently looking for a Validation Specialist to join a leading Biotechnology company based in the Kent area. As the Validation Specialist you will report into the Validation Manager, co-ordinating and executing the validation and re-qualification of facilities, utilities and equipment.

Key Duties and Responsibilities

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

1. Review and update of validation procedures (Policies, Master plans, SOP’s etc.) for equipment and facilities. Establish and maintain Validation Plans as applicable

2. Prepare, execute and report validation protocol including cleaning validation in accordance with EU GMP. Perform qualification and re-qualification temperature mapping activities of storage locations, i.e. refrigerators, freezers and incubators. As well as other equipment and processes. Establish and maintain the re-qualification schedule for all validated equipment.

3. Liaise with Engineering, Quality Assurance and other cross functional departments to ensure that validation is conducted in a timely manner according to the Validation Plan and with minimal disruption to production.

4. Ability to author and execute validation reports, as well as writing validation related procedures Prepare and participate in audits by customers and regulatory authorities, such as the MHRA and FDA.

Role Requirements

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

1. You will ideally hold a relevant degree qualification in an Engineering or Scientific discipline. Those with demonstrated experience and alternative qualification will also be considered.

2. As the Validation Specialist you will have proven industry experience in a highly regulated cGMP compliant environment, such as the biotechnology and/or pharmaceutical markets.

3. A working knowledge and practical experience IQ, OQ, PQ, PV will be required. As will experience of facilities/utilities validation (water and HVAC), equipment validation, temperature mapping and cleaning validation.
Ben Hamlin
Your Recruitment ConsultantBen
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.