Reinigungsvalidierer (m/w/d)
Core
Ensure cleaning procedures for production equipment meet regulatory and operational requirements to guarantee patient safety and prevent cross-contamination.
Role type
Senior IC cleaning validation specialist
Builds
Cleaning validation protocols, risk assessments, and reports for biopharmaceutical production facilities
Domain
Biopharmaceutical manufacturing / GMP compliance
Required skills
Cleaning validation, risk assessment, GMP compliance, deviation investigation, CAPA management, change control, project coordination, cross-functional collaboration, audit preparation
Preferred skills
Qualification, process development, production, quality assurance, optimization of cleaning procedures
Technologies
Microsoft Office
Responsibilities
Plan, execute, and evaluate cleaning validations for production equipment; Create, review, and maintain risk assessments, validation concepts, plans, protocols, and reports; Investigate and handle deviations, OOX results, and error investigations; Support the introduction of new production equipment and technologies; Prepare, accompany, and follow up on customer and regulatory audits
Seniority
Senior, hands-on IC