Job Description A Validation Engineer is required by CareerWise Recruitment for our Co Cork based med device client.
Role of this position Own and support validation activities in a Medical Device regulated environment.
Responsible for all Process Validation Executions.
Responsible for all Software Validation Executions.
Resolution of Problems encountered during validation.
Ensure Consistency in validation/qualification approach across systems and projects.
Provide guidance and direction in the preparation and execution of validation activities.
Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
Maintain Validation system including conducting Periodic Reviews.
Participate in change control processes for manufacturing process and facility modifications.
JOB REQUIREMENTS QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
Minimum of 2 years Quality Assurance / Regulatory affairs experience.
Experience in completing Process Validation's as per CDRH Guidance Experience in using Gamp 4 or Gamp 5 Software V and V Techniques .
Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
Ability to write standard operating procedures, training documents, and regulatory responses.
Experience in statistical Analysis / DOE and DMAIC methods.