LSC have a great contract opportunity for a Process Validation Engineer to join a multinational medical device company based in Cork. The Cork facility is a global centre for product development, manufacturing and supply chain.
If you have a minimum of 2 years’ experience in Quality Assurance/Engineering within regulated industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Ensure validation activities completed comply with US and EU relations, GBSC procedures and EHS requirements.
o Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
o Assist in development of validation strategy and validation plan for equipment and process validations.
o Assist in the development of sampling plans, test plans and data analysis related to process validation.
o Assist in resolution of deviations/ exceptions during qualification activities
o Assist with change control activities in accordance with site procedures.
o Prepare periodic validation review documentation for approval by the business units.
o Maintain site validation registry.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Hons. Degree Quality/ Manufacturing / Engineering / Science
o Minimum of 1 years’ experience in Process, Equipment and Test Method Validation
o Working knowledge of Quality systems (FDA/ISO) within a regulated environment.
o High understanding of Validation practices including the equipment life cycle and regulatory expectations
o Ability to analyze Capability data using MINITAB
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Process Validation Engineer opportunity!