Job Description:
We are seeking a highly skilled Cleaning Validation Specialist to join our team. This is an initial 12-month contract opportunity with our multinational BioTech client in Limerick.
The successful candidate will have experience in executing cleaning validation protocols, writing and approving deviations/GMP documents, and technical writing site reports.
Key Responsibilities:
* Taking Cleaning Validation samples alongside Upstream/Downstream processing.
* Working closely with manufacturing to ensure CIP/SIP and dirty holds are to the correct times and samples are taken.
* Experience in aseptic technique
* Experience in Gowning for ISO7/ISO8
* Generating and Executing Validation Protocols.
* Actively looking for Continuous improvements
* Experience in Validation specifically cleaning validation
* Experience in assessment of cleaning issues during study runs,
* Experienced Technical writer,
* Experience in Deviation/Change control writing,
* Capable of managing a large program, so project management skills would be necessary,
* Generate/review/approval of CV protocols,
* Generate Reports
* Maintain and update Cleaning Validation Plan
* Schedule of cleaning activities with Manufacturing
Requirements:
* Degree qualified in Science/Engineering discipline
* At least 2 years Cleaning Validation experience in the pharmaceutical or Biotechnology setting.