Validation Engineer

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.

Please call Diarmuid Buckley today for further information on 021- 2355432/ 086 072775 or email: dbuckley@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.