Expert sécurité Offres d'emploi - Valais (VS)

Main Responsibilities:

• Lead Environmental Monitoring Performance Qualification (PQ) projects from planning to execution, ensuring adherence to SOPs and regulatory standards (European cGMP, ISO 13485, FDA 21 CFR 820)
• Coordinate with stakeholders (Quality, Operations, Engineering) to align on objectives and timelines
• Execute and oversee validation tasks, including protocol writing, data analysis, reports, and studies (hold time studies and leachable and extractable studies)
• Lead technical investigations and root-cause analyses for deviations, proposing corrective actions and representing Process Validation in cross-functional Risk Assessments
• Act as Subject Matter Expert for Discrepancy Records and Change Requests
• Support regulatory inspections and customer audits
• Create detailed project plans and accurate budget evaluations

Required:

• Relevant working/residency permit or Swiss/EU-Citizenship is required
• Master’s degree in Chemistry, Biotechnology, Life Sciences, or a related field
• Solid experience in Project Management, preferably in MSAT, Quality, or Compliance
• Hands-on experience with GMP-regulated environments
• Strong knowledge of biotechnological/chemical manufacturing processes, validation approaches, and risk management
• Proven ability to write validation protocols, reports, and technical investigations
• Familiarity with regulatory agencies (e.g., Swissmedic, FDA) and customer audits, preferred
• Fluency in English