Validation Engineer

Our client is a global innovator organisation based in Galway with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life.

The Role:

Reporting into the Validation Manager, you the Validation Engineer will join a team of seven and be involved primarily in cleaning and sterilisation validation. This organisation is seeking a team player who has a strong willingness to learn. The role is very diverse which will give you the opportunity to learn across all aspects of Validation.

Key Responsibilities:

  • Responsible for writing, executing & reporting of all validation activities including but not limited to (DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA)
  • Development of project plans for Validation/Qualification projects
  • Validation/Qualification projects will be across a range of production areas which may include, Equipment Qualification (Lyophilisers, Autoclaves, Filling Lines etc), Product Processes, Cleaning, Computerised Systems, Utilities and associated Capital projects
  • Generation, execution and close out of validation projects relating to existing products and new product introductions
  • Participate in project teams and assists in determining project schedules and the relevance of appropriate levels of validation
  • Statistical analysis of data to determine process capability
  • Execution and documenting of process risk assessment / failure mode and effects analysis
  • Perform validation functional testing as required. Track and resolve exceptions during qualification activities and ensure all information is recorded correctly and compliant with GDP

The Person:

  • Minimum of a Diploma in a Science/ Engineering or related discipline and 2-4 years’ experience in a Technical/QA/ Validation Role within the pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes
  • Must possess knowledge of pharmaceutical and medical device regulatory requirements for FDA and HPRA regulated environments
  • Must process knowledge of Pharmaceutical Manufacturing Programs and must possess strong project management and organisational skills. Self-motivation and drive

To learn more apply online or contact Orla Boyle on +353 91 782110.

Salary: On Application Location: Galway