Validation Engineer - Mayo
CPL
Galway
Permanent job for Validation Engineer to join leading manufacturing multinational in Galway. The role: 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. Criteria: Minimum of a Diploma in a Science/ Engineering or related discipline. 2-4 years’ experience in a Technical/QA/ Validation Role within a 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 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. Must be flexible and able to manage multiple priorities simultaneously. Must be an active learner and have a positive leadership attitude. Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Light/Medium Lifting may be required when executing validation projects. Interesteds candidates please contact Annette Murphy on 091 507515 or email your CV in confidence to annette.murphy@cpl.ie. This job originally appeared on RecruitIreland.com.
2380 days ago