Overview

Kenny-Whelan are URGENTLY recruiting a contract Validation Engineer for our Pharma Client in Cork

Contact Jenn Dinan on 0214665408 

Job SPECification for Validation Engineer

 

Job Function:

 

This position will be reporting to the Senior Validation Engineer and will include, but not limited to, the performance of the following duties:

 

  • Write and/or review equipment/facility validation protocols including IT/automated systems (Full Life Cycle).
  • Participate in Equipment and IT System Risk Assessments
  • Assist in the preparation and/or review of process validation protocol.
  • Assist in the preparation and execution of cleaning validation protocols.
  • Provide support and documentation required as part of change management activities.
  • Organise the review and approval process for validation documentation.
  • Examine requirements with respect to Data Integrity/21 CFR part 11 compliance.
  • To work in compliance with regulatory requirements FDA, IMB, GxP, Safety and environmental legislation.
  • Support Quality programmes
  • Interaction and support with project groups
  • Assist in the Training of individuals in the execution of validation protocols

 

 

 

Competencies Required to do the Job:

 

  • B.Sc. degree or Engineering Degree
  • Knowledge of current cGMP, GMP and FDA regulations
  • Minimum of three years validation experience in the pharmaceutical or GMP environment
  • Excellent communication and interpersonal skills and an ability to work independently and as part of a team environment
  • Knowledge of Equipment validation – the writing and execution of validation protocols including FAT/SAT
  • Knowledge of Change Management
  • Knowledge of Risk Assessment tools – FMEA, HACCP, Fault Tree Analysis
  • Knowledge of Validation of Automation/IT Systems
  • An understanding of  Data Integrity / 21 CFR part 11 Requirements
  • Knowledge of Process Validation
  • Knowledge of Cleaning Validation
  • Ability to work directly project groups and vendors to ensure compliance with the relevant policies and procedures.
  • Ability to schedule/co-ordinate and manage projects through all stages or lifecycle
  • Competency is MS Word, MS Excel, MS Access, Lotus Notes

 

 

All applications will be treated with the strictest of confidence

 

Kenny-Whelan:

To apply or for further information please contact Jenn Dinan on 0214665408 or e-mail with your updated CV to [email protected]

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