Description
Role – Validation Engineer – Thermal Mapping / Sterility ValidationLocation – Dublin South, IRL
Type – start ASAP until March 2017
Responsibilities:
- Development of Validation Plans, Cycle Development, Process Qualifications (PQs), Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Systems and Controlled Temperature Chambers.
- Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
- Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
- Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
- Review and Approve validation protocols and assessments from a quality system documentation perspective.
- Participate as required in project activities.
Key Experience:
- Bachelor of Science/Engineering degree or equivalent.
- Knowledge of cGMP’s and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills
- A third level qualification in Science, Engineering or a relevant Quality discipline.
- Understanding of the use of BIs and Thermal Mapping to demonstrate system sterility