Functional Expert CSV Automation
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
We have a newly created position at Lonza for a Functional Expert for CSV (Computer System Validation), this role represents the Center of Excellence for all CSV Automation and Controls. The Functional Expert CSV is assigned to develop and standardize the global approach to Computer System Validation for PLC (Programmable Logic Controller) and DCS (Distributed Control System) qualification.
The position will collaborate with Lonza Quality Unit and support large Capital Project by providing a standardized and robust approach towards CSV for Automation and Controls. The Functional Expert CSV is the owner of the global standardized approach towards CSV.
- Develops Standards and Technologies in all CSV Automation & Controls areas (i.e. PLC and DCS) with global and local regulations as well as existing solutions in Lonza’s network. Involving Quality Assurance, Operations, Engineering and Global Automation covering all aspects of automation. Hosts technical review meetings with associated stakeholders to ensure cross-functional approvals.
- Establish technical packages for standard applications to allow “off the shelf” implementation. Work with Global Automation, vendors and local operations to adjust packages to regional requirements.
- Secures optimal flow of technical information within SGIE (Strategic Growth Initiatives and Engineering) and with project teams as well as any other relevant stakeholders. Promotes and ensures global CSV automation standard adherence and that necessary deviations are highlighted, discussed, well justified and documented.
- Supports CAPEX project teams during concept, design, and start up and qualification (in close collaboration with Shared Service Global Automation and Control of Computer Systems for the Manufacturing. This includes engaging with multiple parties and giving clear directions to the project teams while taking into account the individual project needs.
- Acts a key technical SME (Subject Matter Expert) for CSV provides continuously innovative solutions for CSV methods and ways of executing CSV considering vendor technology and internal experience. Assures buy in of all relevant functions and incorporates innovations in standards
- Bachelor’s or Master’s degree (preferred) in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline
- Extensive experience in CSV, CQV (Commissioning – Qualification - Validation), Automation Engineering or Project Management in the health authority regulated industry
- International working experience is strongly desired
- Experienced in cGMP (current Good Manufacturing Practice) regulatory requirements. GAMP Certification from the ISPE (International Society for Pharmaceutical Engineering) and/or Certified Automation Professional® would be a plus
- Solid internal collaboration and influencing skills and the ability to align diverse, cross-functional teams to successfully transitioning the standards and technologies into execution.
- Persuasive, encouraging, and motivating with strong interpersonal and communication skills.
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.