MSAT Associate Principal Scientist

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

For our client, a global leader in biopharmaceutical manufacturing, we are seeking an experienced

MSAT Associate Principal Scientist (m/w/d)

General Information

• Start Date: 03.08.2026
• Duration: 7 months

Tasks & Responsibilities

• Define and implement process validation strategies for microbial and biopharmaceutical manufacturing processes in compliance with Validation Master Plans (VMPs), SOPs, and regulatory requirements.
• Author, review, and maintain process validation documentation, including study designs, protocols, reports, and process validation lifecycle documentation.
• Develop and maintain Continued Process Verification (CPV) programs and Product Quality Reviews (PQRs) to ensure ongoing process oversight and lifecycle management.
• Support process characterization activities, assess validation data, and collaborate with R&D and cross-functional teams to ensure successful execution of validation activities.
• Coordinate change controls and deviations, support investigations, define corrective actions, and participate in cross-functional risk assessments.
• Act as the process validation subject matter expert during customer audits, health authority inspections, and validation-related Quality activities.
• Support validation training initiatives and drive effective collaboration between MSAT, QA Validation, Cleaning Validation, QA Qualification, and other key stakeholders.

Your Profile

• Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or a related Life Sciences discipline. PhD preferred.
• 5-10 years of experience in biopharmaceutical manufacturing environments.
• Strong experience in process development, process validation, and MSAT environments.
• In-depth understanding of Process Validation Lifecycle, Continued Process Verification (CPV), and Product Quality Reviews (PQRs).
• Solid knowledge of GMP requirements and regulatory expectations for biologics and microbial processes.
• Experience supporting audits, inspections, deviation management, and change control activities.
• Business fluency in English; German is advantageous.