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Validation Engineer

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
12-05-2021
26406-ML

This vacancy has now expired

Validation Engineer- Denmark- 9-month contract

Our global biopharmaceutical client are seeking the support of a Validation Engineer (Autoclaves & Glass-Washers) to support project works at their operational facility. This is an opportunity to support a leading organisation in the biologics sector with numerous upcoming project opportunities.

Responsibilities:
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with FDA standards and local procedures, preferable glass-washers and autoclaves etc. and also to applicable standards
  • Lead daily validation activities including cycle development, performance qualification and revalidation studies as required
  • Execution of thermal mapping equipment/qualification validation programs, including change based requalification and periodic revalidation
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
  • Partake in root cause analysis of system failures/substandard system performances providing technical input
  • Represent team in regulatory audit inspections
 
Experience:
  • Degree or HNC/D qualified in an Engineering based subject or related experience in an Equipment/Validation role
  • Experience within Biotech/pharmaceutical Manufacturing environments with a specific background in Biologics manufacturing equipment to include: Autoclaves, Utensil/Parts washers and Sterilization
  • Experience of coordinating daily validation activities including cycle development, performance qualification and revalidation studies as required
  • Prior experience of execution of thermal mapping equipment/qualification validation programs, including change based requalification and periodic revalidation
  • Solid experience of project lifecycle activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams
  • Demonstrable experience in drafting, executing and reporting of documentation i.e. IQ, OQ, PQ protocols
If you are willing to be based in Denmark and this sounds like something of interest to you please apply now!




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