Cleaning Validation Executor

Cleaning Validation Executor – Contract

Industry: Biopharma

Role Responsibilities:

• Taking Cleaning Validation samples alongside Upstream/Downstream processing.
• Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
• Shows focus & a consistence approach to the role and tasks.
• Excellent people skills.
• Experience in aseptic technique.
• Experience in Gowning for IOS7/ISO8.
• Generating and Executing Validation Protocols.
• Actively look 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.
• An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works.
• Understanding of baseline studies for new equipment • Experienced in coverage testing and clean-into-service.
• Generate/review/Approval of CV protocols.
• Generate Reports.
• Maintain and update Cleaning Validation Plan.
• Schedule of cleaning activities with Manufacturing.
• Liaise with numerous departments.
• Ensure Training is maintained and current.
• Follow all EHS/Safety SOP/Policies.

Education and Experience:

• Experienced in QA Validation activities.
• Execution of cleaning validation protocols.
• Experience on writing and approving Deviations/ GMP documents.
• Technical writing experience in writing site reports.

Duration: 1 year

Location: Limerick