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CSV Engineer

Job description

The CSV Engineer will be responsible for development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.

You will also be responsible for the below duties;

  • Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
  • The CSV Engineer will assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
  • Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
  • The CSV Engineer will review and Approve validation protocols and assessments from a quality system documentation perspective.
  • Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS’s), and any other associated validation issues.
  • Participate and communicate as required in project activities.
  • Develop procedures to manage computerised systems where required
  • Develop and present project plans to project management senior staff

 

The next CSV Engineer should have Bachelor of Science/Engineering degree or equivalent ideally with 3 years’ experience in pharmaceutical or biopharma industry.

You should have a working knowledge of GAMP software development lifecycle and have demonstrated experience in the delivery and management of IS / Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards.

Are you looking to work in an innovative company with excellent career development opportunities? If so apply now!

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