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Validation Specialist - GMP

Kent   •  £35000 - £45000 per annum  •  Permanent, Full time

A leading diagnostics manufacturer requires a Validation Specialist to join its team. Your role will be to co-ordinate and execute the validation and re-qualification of facilities, processes, equipment, and Computer Systems. You must have proven experience in a previous validation position. You must have experience or understanding of GMP.

The Role:

To co-ordinate and execute the validation and re-qualification of facilities, processes, equipment, and Computer Systems (including cleaning validation) where required, to meet the Kent Operations business needs.


May include some or all of the following:

  • Ensure review and update of validation procedures (Policies, Master plans, SOP's etc.) for equipment and facilities
  • Establish and maintain Validation Plans as applicable
  • To prepare, execute and report validation protocol including cleaning validation in accordance with EU GMP
  • To perform qualification and requalification temperature mapping activities of storage locations, i.e. refrigerators, freezers and incubators
  • To perform qualification studies on other equipment and processes
  • Establish and maintain the re-qualification schedule for validated equipment
  • Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner according to the Validation Plan and with minimal disruption to production
  • Attend meetings, both internal and external, representing the department in a professional manner
  • Participate in audits by customers and regulatory authorities
  • To ensure that safe working methods and practices are adopted at all times and in accordance with Company policy for the safety of the postholder and others within the working environment.
  • To be responsible for housekeeping, tidiness and general cleanliness of all areas in which the post holder is working.

Experience Required:

  • Degree level, preferably in Chemistry, Biology, Engineering or a Related Subjects
  • Knowledge of cGMP
  • Understanding of ISO 9001 and ISO13485 Quality Systems
  • General understanding of IQ, OQ, PQ, PV
  • Temperature mapping
  • Cleaning Validation
  • Data Integrity
  • Water system validation
  • HVAC system validation
  • Temperature mapping
  • Ability to author and execute validation reports
  • Ability to write validation related procedures
  • Understanding of calibration principles
  • Ability to challenge systems to ensure that they are slick and value adding as well as being compliant
  • Use of Microsoft Word, PowerPoint and Excel
  • It is important that the post holder is self motivated and can manage multiple tasks. The role carries a high degree of responsibility and has a critical impact on the operation of cGMP related processes.

You must be eligible to work in the UK. Learn more

  • Agency: Cranleigh Scientific
  • Reference: 6919
  • Posted: 18th May 2021
  • Expires: 15th June 2021

Cranleigh Scientific

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