Today, Lonza is a global leader in life sciencesoperatingacross five continents. While we work in science,there’sno magic formulatohow we do it. Our greatest scientific solution is dedicatedpeopleworking 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. Andthat’sthe 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 Sciencesin order tosupport our growth in several business units!
The actual location of this job is in Visp, Switzerland. Relocationassistanceis 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:
1. Guide and support the team in implementing and optimizing cleaning processes, ensuring all documentation meets regulatory compliance requirements.
2. 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.
3. Review and prepare quality records, such as change requests (CRs), deviation reports (DRs), CAPAs, and ensure their timely and accurate processing.
Audit & Regulatory Compliance:
4. Act as the Manufacturing Operations representative and subject matter expert (SME) during internal and external audits, ensuring compliance with GMP standards.
5. 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:
6. 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.
7. Represent manufacturing from the cleaning perspective in the realization of investment projects.
8. Assist in the creation of training strategies, resources, and the training of production staff on proper cleaning processes and procedures.
Internal Projects & Process Improvements:
9. Represent Manufacturing in various internal projects, providing input for the setup, commissioning, and qualification of manufacturing cleaning processes.
10. 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:
11. Collaborate with the cleaning managers, MSAT, QA, and validation teams to plan, implement, and report on cleaning activities.
12. Supervise GMP production and provide organizational oversight to ensure cleaning activities are performed correctly and timely.
13. Ensure the production areas remain technically flawless, clean, and qualified, in compliance with safety, hygiene, environmental, and quality requirements.
Collaboration & Risk Management:
14. Support production planning with the Associate Director of Manufacturing, Bioprocess Engineers, MES/DeltaV Specialists, and Manufacturing Line Specialists regarding cleaning schedules and activities.
15. Lead or participate in root cause analysis, CAPA definition, and change implementation processes within the GMP environment to address any issues related to cleaning.
16. 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:
17. Ensure production services and safety during on-call duties outside regular working hours, addressing any emergency situations or cleaning-related needs as they arise.
18. Participate in meetings, inspections, and audits as the plant representative to provide expert support and ensure customer satisfaction.
Key Skills:
19. GMP & Compliance Expertise: In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements for cleaning processes, including documentation, validation, and audit readiness.
20. Process Optimization & Continuous Improvement: Strong background in driving process improvements using Lean Six Sigma, Kaizen, and other methodologies to enhance cleaning efficiency and quality.
21. 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.
22. Training & Team Leadership: Skilled in developing and delivering training programs for production staff, and leading teams to ensure compliance with cleaning protocols.
23. 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 developingnew ideasin life sciences. In return, we offersatisfactionthat 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.
Reference: R73079