Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented 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.
As a Senior CSV Engineer, Biologics (m/f/d) you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities, including MES. You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as contribute to the ongoing optimization of processes, facilities and internal procedures.
What you’ll get:
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An agile dynamic working culture
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An inclusive and ethical workplace
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Compensation programs that recognize high performance
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A variety of benefits dependent on role and location
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Relocation assistance for eligible candidates and their families
What you’ll do:
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Preparation of commissioning and validation documents for new systems, as well as the supervision of conversion, expansion and new construction projects. This is broken down into CSV activities on new construction projects for critical systems and SLC support for all systems after going live.
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Supervising the junior CSV Engineers including training and coaching.
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Supervision of deviations, changes (GEP and GMP), and CAPAs, as well as review and amelioration of all CSV documents (SOPs, and executables).
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Coordination of CSV executions with internal groups in the Biologics division, as well as external service providers and suppliers.
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Responsible for the presentation of CSV documents during audits and inspections.
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Scheduling and reporting of CSV activities.
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Following the alignment of the CSV strategy with the QA CSV for all Biologics scope.
What we’re looking for:
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University degree in Computer Sciences/Life Sciences/Engineering or similar relevant experience.
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Profound experience with CSV preferably in a CQV-CSV environment, Regulatory Compliance, Project and Lifecycle Management, Quality Assurance and Risk Management, Deviation/CAPA and Change Control.
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Quality Assurance and Validation experience with FDA and EU regulations.
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Work experience in Data Integrity and Security Best Practices.
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Oriented to continuous improvement and process optimization, detail-oriented, technical troubleshooting and problem-solving.
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Beneficial: Certified Quality Engineer (CQE), Certified Pharmaceutical Industry Professional (CPIP), GAMP 5 Certification, Certified Quality Auditor (CQA), Certified Quality Management System (CQMS), Project Management Professional (PMP), Certified Information Systems Auditor (CISA), Certified Data Integrity Professional (CDIP), or similar.
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Fluency in English is required, and German language skills are an advantage.
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 the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
