MSAT Microbial Process Validation Lead

Aristo Group; Oberwallis; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Aristo Group in Visp, Switzerland, seeks an MSAT Microbial Process Validation Specialist to define validation strategies, design and execute studies, and author protocols and reports per regulatory requirements. Drive CPV programs and lifecycle management of validated processes.

You will collaborate with QA, R&D and operations, supervise validation activities, and mentor junior staff while ensuring compliance and timely batch releases.

Qualifikationen

• Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or related Life Sciences (PhD preferred).
• 5–10 years of experience in Biopharmaceutical manufacturing.
• Process validation expertise and GMP knowledge.
• Strong understanding of CPV, PQRs, and regulatory expectations for biologics and microbial processes.
• Business fluency in English; German language skills are advantageous.

Aufgaben

• Design and implement process validation strategies, preparing documents in compliance with Lonza procedures and regulatory guidelines.
• Support R&D during process characterization and ensure flawless validation execution.
• Review/approve characterization documents for regulatory alignment.
• Coordinate validation assessments on changes/deviations; approve deviation/change documents.
• Develop and maintain a continued process verification plan for ongoing oversight.
• Assess and approve Product Quality Reviews to ensure quality standards.
• Participate in cross-functional Risk Assessments to define validation scope.
• Assess validation data against acceptance criteria and support deviation investigations and corrective actions.
• Support customer audits and Ha inspections as a validation specialist.
• Collaborate with QA Ops for batch release of validated processes.
• Support validation training and mentor junior MSAT professionals.
• Organize meetings to enable efficient collaboration across MSAT, QA Validation, Cleaning Validation and QA Qualification.

Kenntnisse

Process validation

CPV

PQRs

GMP requirements

Regulatory expectations

Biopharmaceutical manufacturing

English (business fluency)

Leadership/mentoring

Ausbildung

Bachelor's or Master's in Biology / Biotechnology / Life Sciences (PhD preferred)

Experience in Biopharmaceutical manufacturing

Jobbeschreibung

Aristo Group in Visp, Switzerland, seeks an MSAT Microbial Process Validation Specialist to define validation strategies, design and execute studies, and author protocols and reports per regulatory requirements. Drive CPV programs and lifecycle management of validated processes.

You will collaborate with QA, R&D and operations, supervise validation activities, and mentor junior staff while ensuring compliance and timely batch releases.