Cleaning Validation Engineer is required for our mulitnational biotech client based in South Dublin. In this role you will be responsible for Development of Validation Plans, Cycle Development, Performance Qualifications, Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Systems and Controlled Temperature Chambers (CTCs), in support of NPI and going projects accross the site.
As Cleaning Validation Specialist you will:
o Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
o Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
o Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
o Review and Approve validation protocols and assessments from a quality system documentation perspective.
o Assist in deviation, exception resolution and root cause analysis.
o Participate as required in project activities.
As Cleaning Validation Engineer you will have:
o Bachelor of Science/Engineering degree or equivalent.
o Knowledge of cGMP’s and other worldwide regulatory requirements.
o Problem solving ability and excellent oral and written communications skills
o Knowledge of the use of Biological indicators and Thermal Mapping to demonstrate system sterility/temperature control
o Hands-on experience with temperature mapping equipment, eg Ellab, LIVEs or equivalent
o Bio tech/Pharma background circa 5 years min
Please contact Kathy on 021 4777329 email@example.com or apply directly through this advert.