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Technical Validation Specialist

Technical Validation Specialist

Job Title: Technical Validation Specialist
Contract Type: Contract
Location: Sandwich
Industry:
Salary: Competitive
Start Date: 2020-01-02
Reference: V-46016
Contact Name: Deborah Hunter
Contact Email: deborah.hunter@nextphaserecruitment.com
Job Published: January 02, 2020 17:06

Job Description

We have a very exciting new position available for a Commissioning, Qualification & Validation Engineer for a 6 month contract in Sandwich, Kent UK. You will work for a market leading pharmaceutical company based at the Discovery Science Park as a consultant or freelancer. As is common with these contracts there is a chance of an extension after the initial 6 months. Below, a list of the responsibilities the role entails and also the types of projects you might work on if successful. 

  • Validation of pharmaceutical and biotechnology facilities including HVAC, manufacturing equipment and clean utility systems. Computer system validation
  • Writing and maintaining URS
  • Writing and maintaining DQ, IQ, OQ, FAT and SAT protocols for manufacturing facilities & equipment
  • Executing DQ, IQ, OQ, FAT and SAT protocols
  • Generating documentation for and leading Detailed Design reviews and project Risk Register reviews
  • Working to cGMP standards for MHRA and EU regulatory approval
  • Review and approval of functional specifications, change controls and deviations as well as executed test documentation including IQ/OQ/PQ
  • Environmental mapping of facilities
  • Writing commissioning documents and commissioning of equipment
  • Working with life cycle approach to validation
  • Familiarity with GAMP and 21 CFR Part 11


Example Projects

  • Validation of Testo environmental monitoring system
  • Validation of facility to accommodate melt, spray, congeal equipment
  • Validation of facility to accommodate fluid bed dryer, granulator & coater
  • Validation of Process Control System

For more information and a chance to apply please get in touch with me directly.