Alle Stellen
This position is located in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. For our successful and growing Drug Product focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the Global MSAT DP Qualification & Validation Lead position.
Tasks
- Lead global process control strategy for drug product manufacturing
- Own global strategies for equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV)
- Define and govern global SOPs, standards, templates, and tools aligned with regulations and best practice
- Own qualification strategy for key unit operations: thawing, compounding, filling, lyophilization, and crimping
- Guide Tech Transfer and local MSAT teams on validation strategies, scale‑up, and sampling plans
- Review and approve validation documentation; analyze production data using appropriate statistical methods
- Act as subject‑matter expert during health authority inspections on validation and CPV/OPV
Requirements
- Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field; or equivalent experience
- Expertise in equipment qualification for aseptic drug product manufacturing
- Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats
- Proven experience with regulatory submissions and pre‑approval inspections
- Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred
- Knowledge of risk assessment, deviation management, change control, and root cause analysis
- Excellent English communication, documentation, leadership, and cross‑functional collaboration skills
Benefits
- An agile career and a dynamic work culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.