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CSV Engineer

  1. Dublin
  1. Contract
Competitive
23539FW
  1. Commisions, Qualification and Validation
Date Posted04 Oct 2019
Do you want to be part of one of the top 10 best companies to work for in Ireland?

If so, this could be your chance!

One of our global pharmaceutical clients is looking for a CSV Engineer to join their team at their new
large-scale Bulk Drug Substance facility.

This is a fantastic long term contract opportunity to be part of a fast-paced, €700 million project; working with and learning about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.

CSV Engineer

Duties
• Generates, revises and executes CSV documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR Part 11, ICH Q7 Sections 12 and 13, Eudralex Volume 4 Annex 15, GAMP and other regulatory and industry standard requirements as deemed necessary.
• Works with Manufacturing (MFG), Engineering (ENG), Facilities (FAC), Quality Assurance (QA) and Information Technology (IT) to schedule CSV activities. Manages or supports the CSV plan supporting overall project timelines and site objectives.
• Partners with Quality Assurance IT (QAIT) to ensure policies and procedures reflect up to date regulatory expectations for CSV.
• Responsible for leading or participating in risk assessments associated with CSV activities.
• Generates, revises and/or reviews plans, policies, procedures, reports, specification documentation and vendor qualification documents related to CSV.
• Responsible for providing input, as required, for design documentation to ensure system life cycle for automation of new and upgrades to existing production equipment.
• Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment, as related to CSV.
• Resolve CAPA's, nonconformances, protocol incidents, and change controls related to CSV protocols.
• Serves as a computer system validation subject matter expert for client and regulatory audits.
• Responsible for attending client meetings as an Engineering representative for purposes of addressing CSV.

For further information or to apply, get in touch today!



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