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Cleaning Validation Engineer

Reference ID : 9073MQ
Category :
  • Pharma / Biotech
Date Posted : Nov 6, 2018
Job Location
:
  • Leinster
- Dublin
Experience : Bio tech/Pharma background circa 5 years minimum
Salary : Negotiable - DOE
Employment Type
:
Select Employment Type
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is seeking a Cleaning Validation Engineer for our biotech client at its facility in Dublin. Minimum contract duration 12 months.

Principal Responsibilities

The Cleaning Validation Engineer will work on a project which will require Autoclave Load Qualification, Depyrogenation Tunnel Qualification and SIP Qualification (including Lyophilisers & vessels) in support of a new product introductions. In addition, the qualification of CTC’s across the site to support ongoing projects. 

Responsibilities:

  • Development of Validation Plans, Cycle Development, Performance Qualifications, Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Systems and Controlled Temperature Chambers (CTCs). 
  • 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 Site 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. 
  • Assist in deviation, exception resolution and root cause analysis. 
  • Participate as required in project activities. 

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. 
  • Knowledge of the use of Biological indicators and Thermal Mapping to demonstrate system sterility/temperature control. 
  • Hands-on experience with temperature mapping equipment e.g. Ellab, LIVEs or equivalent. 
  • Bio tech/Pharma background circa 5 years minimum.

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



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