Operation Cleaning BPE

Switzerland, Visp

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is dedicated people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.

And that’s the kind of work we want to be part of.

At our location in Visp, in the canton of Valais, we are constantly looking for Biotechnologists with a relevant background at all levels in Life Sciences in order to support our growth in several business units!

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

This position focuses on overseeing and optimizing cleaning operations in a GMP-compliant manufacturing environment, particularly within a mammalian asset that is in its startup phase. The expert will be responsible for managing the cleaning processes, ensuring regulatory compliance, leading operational teams, and driving continuous improvements across cleaning in manufacturing operations.

• Cleaning Operations & Documentation: Guide and support the team in implementing and optimizing cleaning processes, ensuring all documentation meets regulatory compliance requirements.
• Documentation & Records: Ensure timely, high-quality preparation, creation, optimization, control, and review of manufacturing cleaning-related documents (e.g., Recipes, EBRs, SOPs) in alignment with local procedures.
• Quality Records: Review and prepare quality records, such as change requests (CRs), deviation reports (DRs), CAPAs, and ensure their timely and accurate processing.

• Audit & Regulatory Compliance: Act as the Manufacturing Operations representative and subject matter expert (SME) during internal and external audits, ensuring compliance with GMP standards.
• Risk Assessments: Support and/or execute risk assessments for the cleaning processes related to assigned products and systems to identify areas for improvement and mitigate risks.

• Training & Operational Expertise: Collaborate with the MSAT (Manufacturing Science and Technology) and QA cleaning validation group to improve cleaning process robustness and drive process optimization in routine manufacturing.
• Investment Projects: Represent manufacturing from the cleaning perspective in the realization of investment projects.
• Training Programs: Assist in the creation of training strategies, resources, and the training of production staff on proper cleaning processes and procedures.

• Internal Projects & Process Improvements: Represent Manufacturing in various internal projects, providing input for the setup, commissioning, and qualification of manufacturing cleaning processes.
• Continuous Improvement: Support the optimization of workflows and processes through Lean Six Sigma, Kaizen, and KPI tracking to drive operational excellence.

• Production Support & Supervision: Collaborate with the cleaning managers, MSAT, QA, and validation teams to plan, implement, and report on cleaning activities.
• Compliance & Quality: Supervise GMP production and provide organizational oversight to ensure cleaning activities are performed correctly and timely; ensure the production areas remain technically flawless, clean, and qualified in compliance with safety, hygiene, environmental, and quality requirements.

• Collaboration &
  
  Risk Management:
  
  Support production planning with the Associate Director of Manufacturing, Bioprocess Engineers, MES/Delta
  
  V Specialists, and Manufacturing Line Specialists regarding cleaning schedules and activities.
• Root Cause & CAPA: Lead or participate in root cause analysis, CAPA definition, and change implementation processes within the GMP environment to address any issues related to cleaning.
• Risk Analyses: Carry out risk analyses and ensure that all cleaning operations are carried out safely, efficiently, and in compliance with the highest industry standards.

• On-Call Duty & Customer Support: Ensure production services and safety during on-call duties outside…