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Validation Engineer

Job Title: Validation Engineer
Contract Type: Contract
Location: Cork
Industry:
REF: 82810
Job Published: over 1 year ago

Job Description

Validation Engineer

Our client requires a Validation Engineer for a contracting role of 12 months to be based in Cork. The candidate will play a key role in the planning and execution of validation activities related to new product introductions, product transfers and process changes. You will provide support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of the company validation policies and procedures are addressed. The candidate will act as Subject Matter Expert (SME) on the validation process and deliver coaching and training as required.

KEY RESPONSIBILITIES:
  • Act as Subject Matter Expert on the validation process for the site
  • Contribute to the planning and execution of validation activities related to new product introductions, product transfers and process changes
  • Work as an integral member of project teams to provide guidance and support in establishing optimal validation approach and/or strategy
  • Provide technical assistance to carry out problem solving analysis / root causing investigation
  • Create, execute and review validation related documents, including but not limited to: Protocols, Reports, Change Controls, Validation Plans, etc. in line with site and organizational procedures
  • Maintain the validation process in a state of compliance with external regulatory requirements as well as the company?s standards, while focusing on continuous improvement driving to a best-in-class validation process
  • Support the presentation of executed validation documentation during audits and/or other reviews of the validation process
  • Operate within the company?s SOPs and ensure GxP compliance is maintained at all times

Education, Experience and Skills
  • Degree Engineering or Science Discipline with minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 2yrs of which has been spent carrying out validations
  • Experience in generation of pFMEA
  • Understanding of Statistical Techniques for assessment of process capability
  • Ability to interpret Engineering drawings/specifications
  • In depth knowledge of 21 CFR Part 820 & Part 11 and European regulations associated with the medical device industry
  • High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations
  • Working knowledge of Quality systems (FDA/ISO) within a regulated environment

For further information on this Validation Engineer role in Cork please contact Cliona O?Malley on 091730022 / cliona@ccprecruit.ie
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