Senior MSAT: Microbial Process Validation Specialist

KPC International; Oberwallis; Vor Ort; CHF 140.000 - 180.000; Vollzeit

Zusammenfassung

KPC International is seeking an MSAT Microbial Process Validation Specialist for our Visp, Switzerland site. You will define validation strategies, design studies, and author validation protocols and reports in line with GMP and global regulatory expectations.

You will support CPV programs, PQRs, and lifecycle oversight, collaborating with QA Validation, R&D, and manufacturing to ensure robust processes and batch release readiness.

Qualifikationen

• Broadened knowledge of biopharmaceutical or microbial manufacturing.
• Experience with CPV programs and QMS documentation.
• Strong regulatory understanding for biologics and microbial processes.

Aufgaben

• Develop and implement validation strategies and study protocols.
• Support cross-functional teams during characterization and validation activities.
• Lead/participate in risk assessments and responsible for validation documentation.

Kenntnisse

MSAT

Process Validation

Regulatory Compliance

Cross-functional leadership

Ausbildung

Bachelor's/Master's in Life Sciences

PhD advantageous

Tools

CPV

PQRs

Validation Master Plans

Jobbeschreibung

KPC International is seeking an MSAT Microbial Process Validation Specialist for our Visp, Switzerland site. You will define validation strategies, design studies, and author validation protocols and reports in line with GMP and global regulatory expectations.

You will support CPV programs, PQRs, and lifecycle oversight, collaborating with QA Validation, R&D, and manufacturing to ensure robust processes and batch release readiness.