Headcount Solutions Ltd

<< Back

Cleaning Validation Engineer

Reference ID : 538MQ
Category :
  • Pharma / Biotech
Date Posted : Feb 5, 2019
Job Location
  • Leinster
- Dublin
Experience : Bio tech/Pharma background circa 5 years minimum
Salary : Negotiable - DOE
Employment Type
Select Employment Type
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. 


  • 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

Apply Online

To apply for this opportunity, simply add your details to the form below and upload your CV (in word document format). One of our specialist consultants will contact you to acknowledge your application to discuss the opportunity further.
Your Name *  
Contact Number *  
Email Address *   
Upload CV
Additional Notes

I consent for Headcount Solutions to process my data in accordance with the data regulations as outline within our privacy policy . View Privacy policy here