Operation Cleaning BPE

CH12 Lonza AG; Oberwallis; On-site; CHF 105,000 - 145,000; Full time

Job summary

Lonza Group Ltd. is recruiting for a Manufacturing Operations Cleaning BPE role at our Visp site in Valais, Switzerland. The position focuses on overseeing and optimizing cleaning operations in a GMP environment for a mammalian asset in startup.

You will lead teams, ensure regulatory compliance, and drive continuous improvement in cleaning processes across manufacturing operations. The role requires collaboration with MSAT, QA, and validation teams to enhance process robustness, support

Qualifications

• GMP knowledge and regulatory understanding for cleaning processes.
• Ability to implement and review cleaning documentation and records.

Responsibilities

• Oversee cleaning operations in GMP manufacturing.
• Ensure regulatory compliance and audit readiness for cleaning processes.
• Collaborate with MSAT/QA to improve cleaning process robustness.
• Lead internal projects and apply Lean Six Sigma and Kaizen for improvements.
• Support production planning and supervise GMP production cleaning activities.
• Participate in risk assessments, CAPA definitions and change control.
• Provide on-call support for cleaning-related issues outside regular hours.

Skills

GMP expertise

Compliance

Process optimization

Lean Six Sigma

Kaizen

Cross-functional

Training

Team leadership

Risk management

Job description

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.

Manufacturing Operations Cleaning BPE Role Overview:

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.

Key Responsibilities:

• Cleaning Operations & Documentation: Guide and support the team in implementing and optimizing cleaning processes, ensuring all documentation meets regulatory compliance requirements. 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. 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. 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. Represent manufacturing from the cleaning perspective in the realization of investment projects. 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. Support the optimization of workflows and processes through continuous improvement methodologies such as 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. 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/DeltaV Specialists, and Manufacturing Line Specialists regarding cleaning schedules and activities. Lead or participate in root cause analysis, CAPA definition, and change implementation processes within the GMP environment to address any issues related to cleaning. 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 regular working hours, addressing any emergency situations or cleaning-related needs as they arise. Participate in meetings, inspections, and audits as the plant representative to provide expert support and ensure customer satisfaction.

Key Skills:

• GMP & Compliance Expertise: In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements for cleaning processes, including documentation, validation, and audit readiness.
• Process Optimization & Continuous Improvement: Strong background in driving process improvements using Lean Six Sigma, Kaizen, and other methodologies to enhance cleaning efficiency and quality.
• Cross-Functional Collaboration & Project Management: Ability to work effectively across teams (MSAT, QA, bioprocess engineers) and manage internal projects, from cleaning system setup to qualification.
• Training & Team Leadership: Skilled in developing and delivering training programs for production staff, and leading teams to ensure compliance with cleaning protocols.
• Problem-Solving & Risk Management: Expertise in conducting risk assessments, performing root cause analysis, and implementing corrective actions to mitigate operational risks and maintain safety standards.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves.

At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a significant difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong. You will feel at home at Lonza if you: Take ownership, step forward, and enjoy meaningful responsibility Love solving problems and thrive in a complex, fast-moving environment Are curious, always looking to learn and improve Work collaboratively, contributing to something bigger than yourself Are motivated to make a difference through work that impacts customers and their patients

Why Lonza: We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow. Join us. Be you.