Great opportunity for a Validation Engineer to join our team with our medical device client in Limerick to support the document preparation.
Your responsibilities will include
o Managing Complexity/Technical Accountability Serves as technical expert for the Validation process and responsibilities to ensure compliance.
o Continuous Learning/Managing Risk Resolves & manages technical operational problems in area of expertise .
o Suggest and sometimes may implement innovation and continuous improvement within the Validation process Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
o Facilitates successful team behaviour within Quality Systems and across functional areas Manages relationships externally and internally.
o Builds cross functional and cross-departmental support, fostering overall effectiveness Fosters harmony within Quality Systems.
Your expeirence and education will include:
o A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
o Minimum of 2 – 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
o In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
o High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
Working experience of validation computer systems for use in a FDA regulated environment. Non-Technical Profile Requirements