MSAT: Microbial Process Validation Lead for Biopharma

Actalent; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Actalent is seeking a MSAT Microbial Process Validation Specialist in Visp, Switzerland to provide scientific and regulatory expertise in process validation for biopharmaceutical manufacturing. The role involves defining validation strategies, designing and executing validation studies, and authoring protocols and reports in line with VMPs, SOPs, and global regulatory requirements.

Responsibilities include designing validation studies, supporting R&D during characterization, reviewing

Qualifikationen

• Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology or related Life Sciences; PhD preferred.
• 5-10 years in Biopharmaceutical manufacturing, Process development and validation in MSAT environments.
• Strong understanding of Validation Lifecycle, CPV and PQRs.
• Regulatory expectations for biologics and microbial processes.
• Business fluency in English (written and spoken). German language skills are advantageous.

Aufgaben

• Design and implement validation strategies, preparing validation documents (studies, protocols, reports) per VMPs and regulatory guidelines.
• Support R&D during process characterization ensuring flawless validation execution.
• Review and approve process characterization documents for regulatory alignment.
• Coordinate validation assessments on changes and deviations, approving deviation/change documents.
• Develop and maintain a continued process verification plan for ongoing process oversight.
• Assess and approve Product Quality Reviews ensuring adherence to quality standards.
• Assess validation data for conformance to protocol acceptance criteria and support investigations of deviations.
• Participate in customer audits and HA inspections regarding process validation.

Kenntnisse

Process Validation

CPV

PQRs

Regulatory knowledge

English fluency

Ausbildung

Bachelor's or Master's in Biology/Biotech/Life Sciences

PhD preferred

Jobbeschreibung

Actalent is seeking a MSAT Microbial Process Validation Specialist in Visp, Switzerland to provide scientific and regulatory expertise in process validation for biopharmaceutical manufacturing. The role involves defining validation strategies, designing and executing validation studies, and authoring protocols and reports in line with VMPs, SOPs, and global regulatory requirements.

Responsibilities include designing validation studies, supporting R&D during characterization, reviewing