Process Cleaning Rep (Bio)
Claran Consultants
Kinsale, Cork
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JOB DETAILS
LOCATION
Kinsale, Cork
POSTED
30+ days ago
The Process Cleaning Representative will be responsible for supporting the cleaning program for process equipment and ancillary components in the Biotechnology Manufacturing Facilities in Kinsale.
Duties will include
" Trouble-shoot issues with and optimize cleaning cycles and/or cleaning equipment
" Generate cleaning validation protocols and summary reports
" Execute cleaning validation protocols, including visual inspection and sampling and coordination with other support groups (e.g. operations, maintenance, lab, etc.)
" Author and/or revise cleaning procedures and associated work instructions
" Complete Periodic Review Reports for CIP skids and parts washers to ensure cleaning equipment remains in a qualified state
" Complete review of cleaning batch records
" Provide technical support on cleaning deviations/events and assist in root cause analysis.
" Complete changes associated with cleaning equipment, cleaning cycles and cleaning program.
Qualifications
" Minimum - BSc in either Engineering or Science and at least 2 years similar experience to what is outlined above supporting a pharmaceutical / biopharmaceutical manufacturing site.
Additional Skills/Preferences
" Technical knowledge of cleaning equipment (CIP skids, Parts washers, etc.) and cleaning regimes (chemical, re-circulated washing, etc.)
" Knowledge of qualification/validation requirements and good documentation practices
" Knowledge of Biotech manufacturing processes and understanding of production schedules
" Strong written and verbal communication skills
" Ability to work on own initiative and as part process team consisting of a diverse group of management, production/science and engineering professionals.
About the Company
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