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2000 to 3000 per month
September 12 2021
DPS Engineering requires an intelligent and experienced fellow that will serve as a Validation Engineer for a site secondment in the Cork.
- Owning and supporting validation activities in a regulated environment.
- Being responsible for all Process Validation Execution as well as all Software Validation Execution
- Resolving Problems encountered during validation.
- Ensuring Consistency in validation/qualification approach across systems and projects.
- Providing guidance and direction in the preparation and execution of validation activities.
- Being fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
- Maintaining Validation system including conducting Periodic Reviews
- Participating in change control processes for the manufacturing process and facility modifications.
Experience & Qualification:
- A 3rd Level Degree in Science, Electronics, Mechanical or Industrial Engineering.
- A 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
- Sound understanding and utilisation of Problem Solving Techniques
- Proficiency in the use of MS Word, Powerpoint and Excel.
- 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.
- Being a technically Competent person.