Senior Specialist - Cleaning Validation & Single-Use Tech

MSD Malaysia; Luzern; Hybrid; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Schachen Biotech, a Biotech facility, is seeking a Senior Specialist to lead cleaning validation and Single Use Technology initiatives within GMP manufacturing. The role focuses on developing, executing, and maintaining validation documentation, while collaborating with cross-functional teams to ensure compliant, robust operations.

The ideal candidate has a strong background in cleaning validation, regulatory knowledge, and leadership experience, with English proficiency at high level.

Qualifikationen

• Bachelor’s degree in biology or chemical engineering with GMP experience.
• Minimum 3 years of cleaning validation in GMP environments.
• Strong knowledge of cleaning chemistry, residue limits, analytical methods, and equipment design.
• Excellent English communication (C1).

Aufgaben

• Lead the site cleaning validation program and oversee related documentation (protocols, reports, studies, risk assessments).
• Design and improve cleaning procedures for new products, equipment and processes, including clean-in-place where applicable.
• Support introduction of NPI and new equipment into the validation program with planning and execution.
• Review and approve cleaning-related work instructions, forms, and change controls.
• Investigate cleaning-related incidents, deviations, and out-of-specifications with root cause analysis and troubleshooting.
• Support periodic review of cleaning validation studies and ensure timely closure of issues.
• Train manufacturing, QC, and QA personnel on cleaning validation documents and compliance requirements.
• Prepare for and support internal and external audits and inspections related to cleaning validation.
• Contribute to the development and execution of Single Use Technology strategy and standards across the site.
• Coordinate and track Extractable & Leachable assessments and ensure vendor data is reviewed on schedule.

Kenntnisse

Adaptability

Analytical Testing

Change Request Management

Chemical Engineering

Cleaning Validations

Cross-Functional Collaboration

Data Analysis

Detail-Oriented

Deviation Management

Equipment Qualification

GMP Compliance

Good Manufacturing Practices (GMP)

Manufacturing Processes

New Product Development

Preventive Action

Process Design

Process Hazard Analysis (PHA)

Process Optimization

Regulatory Requirements

Risk Assessments

Root Cause Analysis (RCA)

Strategic Collaborations

Strategic Thinking

Technical Leadership

Ausbildung

Bachelor’s degree in biology or chemical engineering

Master’s degree in biology or chemical engineering

Jobbeschreibung

Schachen Biotech, a Biotech facility, is seeking a Senior Specialist to lead cleaning validation and Single Use Technology initiatives within GMP manufacturing. The role focuses on developing, executing, and maintaining validation documentation, while collaborating with cross-functional teams to ensure compliant, robust operations.

The ideal candidate has a strong background in cleaning validation, regulatory knowledge, and leadership experience, with English proficiency at high level.