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Validation Specialist

  1. NI & Ireland
  1. Contract
  1. Commisions, Qualification and Validation
Date Posted20 Dec 2019

This vacancy has now expired

A fantastic new opportunity with a global pharmaceutical company who is looking for a Validation Specialists to work on their Dublin site.

This is an chance to work for an industry leading pharmaceutical company that invests heavily in Research and Development and produce life changing drugs.

The role of the Validation Specialist would include:
  • Developing and maintaining the site Validation Master Plan.
  • Driving completion of cleaning and sterilization cycle validation activities.
  • Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and revalidation.
  • Develop post OQ documentation in line with the company’s and regulatory requirements.
  • Authoring and reviewing standard operating procedures and technical reports.
  • Supporting global regulatory submissions as needed.
  • Applying LeanSixSigma in the Validation group by:
    • Securing continuity of an appropriate LSS/CEM level of knowledge.
    • Facilitate problem solving & risk assessment (FMEA) projects
 A successful Validation Specialist will have:

  • Experience with upstream cell culture and/or downstream purification of biological molecules.
  • Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale. 
  • Temperature Mapping Experience.
  • Cleaning Validation Experience.
  • Autoclave Experience.
So if you are an experienced Validation Specialist with at least 3 years’ experience within a similar role and are looking for exciting new opportunities to expand your experience, get in touch today.

The candidate must have the rights to work in the location stated in the job advert.

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