Process and Technical Operations Validation Specialist (m/f)

REFERENZNUMMER:

258319/11

IHRE AUFGABEN:

-Lead and participate in the development and assessment of strategies, execution and reporting of validation activities following equipment or process changes
-Write, review and approve OQ, DV, PQ and PPQ protocols, strategies and reports for CIP (Clean-in-place) validation
-Maintain and develop expertise in CIP/COP validation
-Responsibility for the planning of revalidation activities
-Provide technical support, quality, engineering and manufacturing organisations (lead or support deviations or investigations, root cause analysis, CAPA definition and implementation)
-Participate in internal or external assessments and support processes with timely closure of observations and audit items
-Lead or support CIP/COP training for the manufacturing organisation, following the cGMP and GDP and other applicable guidelines

IHRE QUALIFIKATIONEN:

-Technical background in biotechnology, the pharmaceutical industry, process engineering, chemistry or equivalent
-Proven relevant experience in the field of operational CIP (Clean-in-place) validation
-Fluency in English (both spoken and written), preferably also in French

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist