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CSV Engineer

Reference ID : 101MQ
Category :
  • Pharma / Biotech
Date Posted : Jun 19, 2020
Job Location
:
  • Leinster
- Dublin
Experience : 5 Years
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is seeking a CSV Engineer for a Dublin-based biotech facility. This is a contract role for an initial 12 months duration with potential to roll on.

Principal Responsibilities

CSV Engineer

The success candidate will have at least 5 years’ experience in:
- cGMP Regulated Environment
- Computer system validation lifecycle
- Working knowledge of GAMP software development lifecycle

Key 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.
  • Knowledge of cGMP’s and other worldwide regulatory requirements.
  • Problem solving ability and excellent oral and written communications skills.
  • Understanding of the computer system validation lifecycle.

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



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