The contract lasts until the end of 2026, potentially longer, hybrid (3 days on-site, 2 days remote) and based in Visp, Switzerland. This is an excellent opportunity to join a leading pharmaceutical company.
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
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