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Validation Specialist

Job Description

Xcede are proud to be working with a leading provider of systems & software solutions into the Pharmaceutical, Biotech & Energy industries to recruit a Validation Specialist based from their Middlesbrough office

Job Role: Validation Specialist

Location: Middlesbrough

Salary: £40,000 - £55,000 pa plus benefits

As a Validation Specialist your remit will include:

  • Modify, review, and create Validation Documents, Quality Plans, Specifications, Test Specifications, Validation Reports
  • Carry out Assessments of computerised systems to ensure that specifications and current regulations are met.
  • Keep abreast of current Computer Validation related regulations
  • Carry out system testing against specifications, record test results and review test results in line with current validation regulations.
  • Work within the regulations required for pharmaceutical projects and manufacturing, e.g., GMP, GAMP.

What you will bring to the company:

You'll have working knowledge in Validation in one or more of the following areas

(Computer System/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/ Pharmaceutical (FDA/MHRA regulated industries).

Typical regulatory knowledge would be in: -

* cGMP and GxP, * GAMP * FDA 21 CFR Part 11 * Annex 11 * Data Integrity

What they promise to offer:

  • A Laptop is provided with the role
  • Whilst working from home is not a routine element of company policies, it is possible to do so should a situation arise that requires this. VPN network access is provided to senior roles to allow you to accomplish this.
  • Core working hours allow flexibility of start or end times each day and an early finish on Fridays where criteria have been met
  • Employee rewards for The Greatest Mover, decided on nominations received by your colleagues and 'The Better Book Club' where you are rewarded for reading book and writing a review.
  • After 12 months each employee is part of a medical healthcare plan
  • After 24 months each employee's spouse can be enrolled in the medical healthcare plan
  • Children can be added to the medical healthcare plan at a small cost to the employee
  • Pension - the company operates a workplace pension in line with government regulations Employee Contribution Employer Contribution 5% salary 4% Salary
  • Holidays - 25 days per annuum, pro rata if employment commences part through the year - An additional 1-day bonus holiday after each 5 years of service