Senior Specialist - Cleaning Validation & Single-Use Tech

MSD Switzerland; Ruswil; Vor Ort; CHF 95.000 - 140.000; Vollzeit

Zusammenfassung

MSD Switzerland seeks a senior specialist to lead cleaning validation and single use technology (SUT) activities at the Schachen site. You will develop, execute, and maintain validation documentation, assess risks, and collaborate with cross-functional teams to ensure compliant manufacturing operations.

The role requires a strong background in GMP manufacturing, 3+ years in cleaning validation, and expertise in regulatory guidelines.

Qualifikationen

• Bachelor’s degree in biology, chemical engineering, or a related discipline with at least 6 years or Master’s degree with at least 4 years in GMP manufacturing in pharma/biotech.
• Minimum 3 years of experience in cleaning validation within GMP environment.
• Knowledge of regulatory guidance (FDA, EMA, PIC/S, ISPE, etc.).
• Excellent analytical skills and attention to detail.
• Working knowledge of cGMP regulations.
• Demonstrated supervisory and leadership skills.
• Fluent English (C1).

Aufgaben

• Lead cleaning validation program development, updates, and execution of documents (protocols, reports, studies, risk assessments).
• Design and improve cleaning procedures for products, equipment, and processes, including clean-in-place.
• Support introduction of new products/equipment into validation via technical assessment and planning.
• Review and approve cleaning-related documents and change controls.
• Investigate deviations and incidents with root cause analysis and corrective actions.
• Train personnel on cleaning validation compliance and documentation.
• Prepare for audits and inspections related to cleaning validation.
• Contribute to SUT strategy, maintain flow diagrams, and standardize materials and connectors.
• Coordinate SUT requirements for commissioning, qualification, verification, procurement, and project 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

Manufacturing Processes

New Product Development

Preventive Action

Process Design

Process Hazard Analysis

Process Optimization

Regulatory Requirements

Risk Assessments

Root Cause Analysis

Strategic Collaborations

Strategic Thinking

Technical Leadership

Ausbildung

Bachelor’s degree in biology or chemical engineering

Master’s degree in related field

Jobbeschreibung

MSD Switzerland seeks a senior specialist to lead cleaning validation and single use technology (SUT) activities at the Schachen site. You will develop, execute, and maintain validation documentation, assess risks, and collaborate with cross-functional teams to ensure compliant manufacturing operations.

The role requires a strong background in GMP manufacturing, 3+ years in cleaning validation, and expertise in regulatory guidelines.