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.
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.
- 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
- 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