MSAT Microbial Process Validation Specialist (CPV)

fortil; Meyrin; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Fortil seeks an experienced MSAT Microbial Process Validation Specialist in Switzerland to establish, monitor, and qualify microbiological processes across the production lifecycle. You will work with R&D, QA, Production, and Validation teams to ensure regulatory compliance and robust, reproducible results.

Responsibilities include designing validation strategies, authoring protocols and reports, supporting tech transfer and scale-up, and leading CPV and PQR activities.

Qualifikationen

• Master’s degree in biotechnology, microbiology, biochemistry, process engineering, or related field.
• PhD preferred; Bachelor’s or Master’s degree in Life Sciences with related discipline considered.

Aufgaben

• Design and implement validation strategies across the product lifecycle in GMP-compliant settings.
• Author and review validation documentation, study designs, reports, and technical assessments.
• Provide MSAT support during process characterization, tech transfer, scale-up, and manufacturing.
• Collaborate across MSAT, Manufacturing, QA, and Engineering to ensure lifecycle milestones.
• Lead or support risk assessments to define validation approaches and critical process parameters.
• Evaluate data against acceptance criteria to identify trends and improvement opportunities.
• Support investigations related to deviations and CAPA implementation.
• Assess impact of process changes and participate in change control activities.
• Develop and maintain CPV programs and monitor process performance.
• Contribute to Product Quality Reviews and lifecycle activities with technical assessments.
• Act as MSAT SME during audits and regulatory inspections.
• Partner with QA to support validation campaigns and batch disposition.
• Facilitate cross-functional collaboration to align validation objectives.
• Mentor junior colleagues and support training on process validation best practices.

Kenntnisse

Process development

Process validation

MSAT environments

GMP knowledge

CPV & PQRs

Regulatory knowledge

English fluent

German a plus

Biopharma manufacturing

QA collaboration

Ausbildung

Master’s degree in biotechnology/bi microbiology/biochemistry/process engineering

Bachelor’s or Master’s degree in Life Sciences (Biology, Biotechnology, Microbiology etc.)

Jobbeschreibung

Fortil seeks an experienced MSAT Microbial Process Validation Specialist in Switzerland to establish, monitor, and qualify microbiological processes across the production lifecycle. You will work with R&D, QA, Production, and Validation teams to ensure regulatory compliance and robust, reproducible results.

Responsibilities include designing validation strategies, authoring protocols and reports, supporting tech transfer and scale-up, and leading CPV and PQR activities.