Validation Engineer required for medical device manufacturer based in Fermoy, Co. Cork to support the validation activities by formulating and executing validation plans for medical devices.
As Validation Engineer you will be required to:
o Own and support validation activities in a Medical Device regulated environment.
o Responsible for all Process Validation Execution
o Responsible for all Software Validation Execution
o Resolution of Problems encountered during validation.
o Ensure Consistency in validation/qualification approach across systems and projects.
o Provide guidance and direction in the preparation and execution of validation activities.
o Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
o Maintain Validation system including conducting Periodic Reviews
As Validation Engineer you will have:
o 3rd Level Degree. (Preferably in a Science, Electronics, Mechanical or Industrial Engineering)
o Minimum of 2 years Quality Assurance / Regulatory affairs experience.
o Experience in completing Process Validation’s as per CDRH Guidance
o Experience in using Gamp 4 or Gamp 5 Software V and V Techniques
o Sound understanding and utilization of Problem Solving Techniques
o Proficient in the use of MS Word, Power-point and Excel.
o Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
o Ability to write standard operating procedures, training documents, and regulatory responses.
o Experience in statistical Analysis / DOE and DMAIC methods.
For full details on this role please contact Kathy Gillen on 021 4777329 firstname.lastname@example.org or apply directly through this advert.