Bioprocess Engineer, Cleaning Expert 80%-100%
On-siteVisp, Valais, Switzerland
Job Summary
Lead and coordinate GMP investigations related to cleaning, owning end-to-end cleaning deviation management from root cause analysis to impact assessment and closure. Review manufacturing data, electronic batch records, and analytical results to support deviation investigations and product impact assessments. Collaborate with cross-functional teams including Manufacturing, Quality Assurance, MSAT, Engineering, Validation, and QC to resolve complex operational and GMP issues. Support regulatory inspections, customer audits, and internal audits by presenting investigation outcomes and CAPA strategies. Provide coaching and guidance to manufacturing personnel on deviation reporting, investigation practices, and quality culture. Contribute to process monitoring, risk management activities, and operational excellence projects to improve compliance and process reliability. Join Lonza's growing Biologics organization in Visp, Switzerland, driving operational excellence for innovative bioconjugate manufacturing processes.
Required Qualifications
- Degree in Biotechnology, Biochemistry, Biochemical Engineering, Life Sciences, or a related scientific discipline (Bachelor's, Master's, or PhD)
- Experience in biopharmaceutical, biotechnology, or GMP-regulated manufacturing environments, particularly in upstream or downstream processing
- Understanding of equipment cleaning, cleaning validation, contamination control, or related process engineering activities
- Knowledge of GMP requirements, quality systems, and manufacturing documentation practices
- Familiarity with USP/DSP equipment and process equipment design within biotechnology production environments
- Strong communication and collaboration skills, with the ability to work effectively across multiple functions and stakeholders
- A structured, solution-oriented mindset with a passion for continuous improvement, learning, and driving operational excellence
- Relocation assistance is available for eligible candidates and their families, if needed
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