Job Description
A Validation Engineer is required by CareerWise Recruitment for our Co Cork based medical 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 Validations as per CDRH Guidance.
* Experience in using GAMP 4 or GAMP 5 Software V & 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.