Validation Engineer
Brightwater
Galway
A leading employer in Galway requires a team player to step into their established validation team. Ideally you will have at least 2 years in a Quality role with some experience of carrying out or supporting validation projects. Main Duties: 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. Participates 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. Ensure all information is recorded correctly and compliant with GDP. Qualifications: Here are the minimum qualifications and essential functions for this position: 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. Experience in Freeze Drier/ Lyophilisation validation will be considered a distinct advantage. Must possess knowledge of pharmaceutical and medical device regulatory requirements for FDA and HPRA regulated environments. Must process knowledge of Pharmaceutical Manufacturing Programs. Must possess strong project management and organizational skills. Self-motivation and drive. Excellent interpersonal, communication (written & oral) & technical report writing skills. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2408 days ago