MSAT Associate Principal Scientist - Process Validation

Gi Group; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Gi Group in Switzerland seeks an MSAT Associate Principal Scientist (m/w/d) to lead validation activities for a global biopharmaceutical manufacturing leader on a 7-month assignment starting 03.08.2026.

Responsibilities include defining and implementing process validation strategies, authoring and reviewing validation documentation, and developing CPV programs and PQRs to ensure lifecycle oversight. Collaboration with R&D, QA Validation, and cross-functional teams is required.

Qualifikationen

• Bachelor's or Master's degree in Life Sciences; PhD preferred.
• 5–10 years of biopharma manufacturing experience.
• Strong background in process development and validation.
• In-depth knowledge of CPV and PQRs.
• GMP knowledge for biologics and microbial processes.
• Experience supporting audits and change control.

Aufgaben

• Define and implement process validation strategies per VMPs, SOPs, and regs.
• Author, review, and maintain validation docs and lifecycle records.
• Develop CPV programs and Product Quality Reviews.
• Support process characterization and data assessment with cross-functional teams.
• Coordinate change controls, deviations, investigations, and CAPAs.
• Act as PV SME during audits and inspections.
• Support validation training and cross-functional collaboration.

Kenntnisse

Process validation

MSAT environments

GMP knowledge

Regulatory compliance

Audits & inspections

English proficiency

German language (adv)

Ausbildung

Bachelor's or Master's in Life Sciences

PhD preferred

Jobbeschreibung

Gi Group in Switzerland seeks an MSAT Associate Principal Scientist (m/w/d) to lead validation activities for a global biopharmaceutical manufacturing leader on a 7-month assignment starting 03.08.2026.

Responsibilities include defining and implementing process validation strategies, authoring and reviewing validation documentation, and developing CPV programs and PQRs to ensure lifecycle oversight. Collaboration with R&D, QA Validation, and cross-functional teams is required.