A Process Validation Engineer required for an expanding medical device faciltiy based in Cork. A great opportunitiy to join a state of the art manufactruing facility and playing a key role in the the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes.
As the QA Process validation Engineer you will provides support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.
Your responsiblities will include:
o Ensuring validation activities completed are in compliance with US and EU relations, GBSC procedures and EHS requirements
o Assisting in development of validation strategy and validation plan for equipment and process validations.
o Assisting in the development of sampling plans, test plans and data analysis related to process validation.
o Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
o Review and approve documents prepared by project teams, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
o Assist in resolution of deviations/ exceptions during qualification activities
As QA Process Validaiton Engineer you will have:
o Hons. Degree Quality/ Manufacturing / Engineering / Science
o Minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 2 years of which has been spent carrying out validations)
o Working knowledge of Quality systems (FDA/ISO) within a regulated environment
o Process validation experience
o Ability to analyse Capability data using MINITAB
o Ability to interpret Engineering drawings/specifications
o Familiarity in areas of various inspection techniques
o Equipment qualification and test method validation experience
o Six Sigma Certification (Green Belt / Black Belt)
Please contact Kathy at LSC on 021 4777329 for full detail of role or apply directly through this advert.