Senior Cleaning Validation & Single-Use Lead

MSD Malaysia; Schachen; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

MSD Malaysia is seeking a Senior Specialist for Cleaning Validation and Single Use Technology at the Schachen site. The role focuses on leading cleaning validation programs, developing validation documentation, and supporting new equipment integration into validation activities.

The candidate will drive risk-based improvements, oversee SOPs, and collaborate with QA, QC and Operations to ensure regulatory compliance and robust manufacturing operations.

Qualifikationen

• Bachelor’s or Master’s degree in biology, chemical engineering or related field with GMP manufacturing experience.
• Minimum 3 years in cleaning validation within a GMP-regulated environment.
• Strong knowledge of cleaning chemistry, residue limits, analytical methods and equipment design.
• Familiarity with FDA, EMA, PIC/S, ISPE guidance and cGMP regulations.
• Excellent analytical skills, detail-oriented, and able to lead teams.

Aufgaben

• Lead cleaning validation program, develop/update protocols, reports, studies and risk assessments.
• Design/optimize cleaning procedures for new products, equipment and processes.
• Support NPI and new equipment integration into validation programs with planning and execution.
• Review/approve cleaning-related instructions, forms, and change controls.
• Investigate incidents, deviations and OOS results; perform root cause analysis.
• Train personnel on cleaning validation documentation and compliance requirements.
• Prepare for internal/external audits and inspections related to cleaning validation.
• Contribute to SUT strategy, maintain flow diagrams, standards and documents.
• Coordinate and track Extractable & Leachable assessments and vendor data.
• Review and approve SUT risk assessments, calculations and reports.

Kenntnisse

Leadership

Cleaning validations

GMP Compliance

Process Design

Risk Assessments

Analytical Testing

Ausbildung

B.S. or equivalent in biology/chemical engineering

M.S. with 4+ years GMP manufacturing experience

Jobbeschreibung

MSD Malaysia is seeking a Senior Specialist for Cleaning Validation and Single Use Technology at the Schachen site. The role focuses on leading cleaning validation programs, developing validation documentation, and supporting new equipment integration into validation activities.

The candidate will drive risk-based improvements, oversee SOPs, and collaborate with QA, QC and Operations to ensure regulatory compliance and robust manufacturing operations.