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CSV Engineer

Reference ID : 0392MQ
Category :
  • Pharma / Biotech
Date Posted : Nov 6, 2018
Job Location
:
  • Leinster
- Dublin
Experience : Minimum 3 years experience as per list below.
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is seeking a CSV Engineer for our biotech client at its facility in Dublin. Minimum contract duration 12 months.

Principal Responsibilities

  • Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports. 
  • Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards. 
  • 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 
  • 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 

Qualifications & Requirements

  • Bachelor of Science/Engineering degree or equivalent. 
  • Candidates must have at least 3 years’ experience in: 
    - cGMP Regulated Environment 
    - computer system validation lifecycle 
    - working knowledge of GAMP software development lifecycle 
  • Ideally, candidates will 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. 

 

For further information, please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie



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