MSAT Microbial Process Validation Specialist

KPC International; Oberwallis; Vor Ort; CHF 140.000 - 180.000; Vollzeit

Zusammenfassung

KPC International is seeking an MSAT Microbial Process Validation Specialist for our Visp, Switzerland site. You will define validation strategies, design studies, and author validation protocols and reports in line with GMP and global regulatory expectations.

You will support CPV programs, PQRs, and lifecycle oversight, collaborating with QA Validation, R&D, and manufacturing to ensure robust processes and batch release readiness.

Qualifikationen

• Broadened knowledge of biopharmaceutical or microbial manufacturing.
• Experience with CPV programs and QMS documentation.
• Strong regulatory understanding for biologics and microbial processes.

Aufgaben

• Develop and implement validation strategies and study protocols.
• Support cross-functional teams during characterization and validation activities.
• Lead/participate in risk assessments and responsible for validation documentation.

Kenntnisse

MSAT

Process Validation

Regulatory Compliance

Cross-functional leadership

Ausbildung

Bachelor's/Master's in Life Sciences

PhD advantageous

Tools

CPV

PQRs

Validation Master Plans

Jobbeschreibung

KPC International - Excellence from Concept to Completion

KPC International began operations in 2001. Our team of engineers and scientists has helped our clients achieve project success across the globe within the pharmaceutical and biopharmaceutical industry.

We specialise in Plant Facility Start-Up, from Strategy and Planning through to Execution and Operational Readiness. We are proud to support our clients in delivering life-changing therapies to patients.

MSAT Microbial Process Validation Specialist

We are looking for an experienced MSAT Microbial Process Validation Specialist to join a leading biopharmaceutical manufacturing environment in Visp, Switzerland

This is an excellent opportunity for a validation professional with strong scientific expertise in microbial or biopharmaceutical manufacturing who can combine technical depth, regulatory knowledge, and cross-functional leadership to support the lifecycle of validated manufacturing processes.

The role as an MSAT Microbial Process Validation Specialist, you will provide scientific and regulatory expertise for process validation activities across biopharmaceutical manufacturing. You will define validation strategies, design and execute validation studies, and author and review validation protocols and reports in accordance with Validation Master Plans (VMPs), SOPs, GMP requirements, and global regulatory expectations.

A key part of the position will also be developing and maintaining Continued Process Verification (CPV) programs and supporting Product Quality Reviews (PQRs) to ensure robust ongoing process oversight and lifecycle management.

KEY RESPONSIBILITIES

• Develop and implement process validation strategies, including study designs, protocols, assessments, and final reports.
• Support R&D and process development teams during process characterization and subsequent validation activities.
• Review and approve process characterization documentation for scientific robustness and regulatory compliance.
• Perform validation assessments associated with process changes and deviations and support approval of relevant change and deviation documentation.
• Develop, implement, and maintain Continued Process Verification (CPV) plans and ongoing process monitoring strategies.
• Assess and approve Product Quality Reviews (PQRs) in accordance with applicable quality standards.
• Lead or participate in cross-functional risk assessments to establish appropriate validation and study scope.
• Evaluate validation data against predefined protocol acceptance criteria.
• Support investigations of validation deviations and the definition of appropriate corrective and preventive measures
• Act as a process validation subject-matter expert during customer audits and Health Authority inspections.
• Collaborate closely with QA Operations to support batch release activities for processes undergoing validation.
• Support validation training programs and mentor junior MSAT validation professionals.
• Drive effective collaboration across MSAT, QA Validation, Cleaning Validation, QA Qualification, R&D, and other key stakeholders.

QUALIFICATIONS AND EXPERIENCE

Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or another relevant Life Sciences discipline. A PhD is advantageous.

Approximately 5-10 years of relevant experience across areas such as:

• Biopharmaceutical or microbial manufacturing
• MSAT / Manufacturing Science & Technology environments

You should have strong working knowledge of:

• Process Validation Lifecycle principles
• Continued Process Verification(CPV)
• Product Quality Reviews(PQRs)
• Regulatory expectations for biologics and microbial manufacturing processes
• Validation-related deviations, changes, investigations, and risk assessments

Languages

English: Business fluency, written and spoken

German: Advantageous but not essential

Why Join KPC Intern

Join a growing international team supporting some of the world's leading pharmaceutical and biotechnology companies. You'll have the opportunity to work on major global capital projects while developing your technical expertise across commissioning, qualification and validation act

ivities.KPC International offers an inclusive environment where you can broaden your experience, work alongside industry experts, and contribute to the successful delivery of life-changing medicines

KPC International is an Equal Opportunity Employer