Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d)
lonza.com
- Job written in
- English
- Location
- Visp
- Work type
- On-site
- Type
- Full-time
The Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d) role is based in Visp, Switzerland, at Lonza, a leading biopharmaceutical company. Lonza specializes in manufacturing life-changing therapies, ensuring the highest standards of quality, safety, and reliability. The engineer will focus on leading critical deviation investigations to maintain these standards. The main responsibilities include conducting structured investigations for various manufacturing events, collaborating with cross-functional teams to identify root causes, and developing corrective actions. The engineer will also draft, review, and approve deviation records, ensuring compliance with GMP requirements. Additionally, the role involves supporting internal and regulatory inspections and contributing to continuous improvement initiatives. To qualify, candidates must have experience in biotechnology, biopharmaceutical, or GMP-regulated manufacturing environments. A strong understanding of GMP requirements, manufacturing processes, and quality risk management is essential. Candidates should also possess a degree in a relevant scientific discipline or equivalent experience. Excellent stakeholder management and communication skills are crucial for collaborating with various teams. Nice-to-have skills include the ability to analyze complex technical data and develop scientifically justified conclusions. The role offers an agile career path, dynamic working culture, and opportunities to work with highly experienced teams. Lonza values diversity and inclusivity, fostering an environment where everyone's ideas can improve millions of lives. What the role asks for: - Experience in biotechnology, biopharmaceuticals, pharmaceuticals or GMP-regulated manufacturing environments. - Experience in leading or supporting investigations of deviations, root cause analyses, CAPA management and quality processes. - Strong understanding of GMP requirements, manufacturing processes, cleaning validation, qualification activities and quality risk management principles. - Ability to analyze complex technical data, evaluate product and process impacts and develop scientifically sound conclusions. - Excellent stakeholder management and communication skills. - Degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, Life Sciences, Pharmaceutical Sciences or a related scientific discipline, or equivalent experience in a relevant environment. - Strong organizational skills to manage multiple priorities, ensure timely execution and maintain high documentation standards.
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