Associate Director CSV Engineer (m/f/d)

Switzerland, BaselSwitzerland, VispToday, 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.The CSV Engineer represents the Global Engineering for all CSV Automation and Controls (OT) & is assigned to support the CSV Global Lead & respective Projects to develop/standardize the global approach to Computer System Validation for PLC and DCS qualification.The CSV Engineer coordinates/manages the improvements, updates and trainings of the global CSV procedures. The CSV Engineer will support various project delivery as appropriate and the project review team on matters relating to CSV.Key responsibilities:To support the Global CSV Lead with development and maintenance of standards and technologies, across all Automation & Control areas. This will encompass continuous adherence to industry regulations and identifying opportunities to embrace potential future new technologies into the Lonza framework.To establish and maintain validation/qualification packages for standard applications to allow “off the shelf” implementation. Cooperate with Global Automation, vendors and local operations to adjust packages to regional requirements.To support projects for PEP, PQP and C&Q/CSV Plan development with the C&Q Manager for CSV related topics.To provide support to CAPEX project teams during concept, design, development, start up, commissioning and qualification in close collaboration with Project Management, CQV Leads, Automation and Operations teams. This includes engaging with multiple parties and giving clear CSV directions to the project teams while taking into account the individual project needs.To continuously seek and provide innovative solutions for CSV methods and ways of executing CSV concepts considering incorporating vendor technology and internal learnings.To support the Quality Unit as the CSV SME during audit/inspections.To conduct assessments and/or reviews of existing CSV methods and SOP’s in respect of robustness and adherence to health authority expectations, and to propose and execute effective CAPA should gaps be identified.Maintain compliance with all pertinent safety policies, rules and regulations.Key requirements:Bachelor or Master's degree in IT / Automation or related field.Experience working in a GMP-related environment in the pharmaceutical industry: CSV and/or CQV (Commissioning – Qualification - Validation).Proficient experience in Project Management and Stakeholder Management.English fluent, German an advantage. #J-18808-Ljbffr