MSAT EM Expert

Manpower
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Location: Switzerland - Visp
Contract Duration: July 1, 2026 ? December 27, 2026
Work Model: Hybrid (2 days home office)

About the Role

For one of our pharmaceutical and biotechnology clients in Switzerland, we are currently looking for an experienced MSAT EM Expert to support Manufacturing Science & Technology activities within a GMP-regulated environment.

As a Subject Matter Expert, you will play a key role in Environmental Monitoring (EM) Performance Qualification activities, validation projects, technical investigations, and cross-functional collaboration to ensure compliance with GMP and regulatory requirements.

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Key Responsibilities

• Lead Environmental Monitoring Performance Qualification (EM PQ) activities and ensure compliance with established procedures.
• Coordinate and communicate effectively with all project stakeholders.
• Prepare, review, and approve validation protocols and reports.
• Execute validation activities when required and ensure compliance with GMP, ISO 13485, and FDA requirements.
• Participate in and facilitate cross-functional risk assessments.
• Assess validation data against predefined acceptance criteria.
• Support investigations, root cause analyses, and implementation of corrective actions.
• Contribute as Subject Matter Expert to Change Controls and Discrepancy Records.
• Develop and improve validation programs, procedures, and SOPs.
• Support regulatory inspections and customer audits.
• Provide project planning, resource estimation, and budget evaluation.

Required Qualifications

• Master's degree in Chemistry, Biotechnology, Life Sciences, or a related scientific field.
• Proven experience in Manufacturing Science & Technology (MSAT), Validation, Quality, or Compliance functions.
• Strong knowledge of biotechnological and/or chemical manufacturing processes.
• Extensive experience within a GMP-regulated pharmaceutical environment.
• Solid understanding of process validation, qualification strategies, and risk management principles.
• Experience working with cross-functional stakeholders and multidisciplinary teams.
• Knowledge of regulatory requirements including EU GMP, ISO 13485, and FDA regulations.
• Experience interacting with health authorities (e.g. Swissmedic, FDA) is considered a strong advantage.

What We Offer

• Opportunity to join a leading pharmaceutical/biotech environment.
• Challenging and impactful project assignment.
• Hybrid working model with flexibility.
• International and collaborative working environment.

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Interested candidates are invited to submit their CV in English E-Mail auf jobroom.jobcourier.ch ansehen

Branche: Ingenieurwesen

Funktion: Qualitätskontrolle / Qualitätssicherung