Lead Engineer, Engineering - Validation

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. 

This role will provide day-to-day Validation activities support in accordance with approved SOPs / Policies for a GMP Biotech manufacturing facility. Supports Validation activities related to validation of facility, equipment utility, computer system, cleaning, and sterilization. Recommends improvements to the validation approach and site operations. Collaborates with other site  

functions to implement improvements projects. 

Key Responsibilities: 

• Lead or support Validation activities related to the validation of facility, equipment utility, computer systems, cleaning, and sterilization. 

• Complete day-to-day Validation activities in strict accordance with approved Validation SOPs, Plans, and Policies. 

• Develop and complete Validation Protocols and Reports, including supporting site discrepancies and deviations investigation/closure. 

• Participate in system design reviews to ensure compliance with user requirements, good engineering practices, validation requirements, and regulatory standards. 

• Review and approve Validation Protocols and Reports, ensuring site discrepancies and deviations are investigated and closed. 

• Participate in the Site Validation Maintenance Program. 

• Develop Validation Plans for small to medium-scale change implementation projects and ensure validation execution activities meet scheduled timelines. 

• Coordinate with other Engineering functions, End-User, and Quality teams to ensure Validation activities are completed as planned and align with user, Lonza standards, and regulatory requirements. 

• Review Engineering documents associated with commissioning and validation activities. 

• Evaluate and propose improvements to equipment/systems, processes, and operations to boost safety and process efficiency. 

• Review and assess Site Change Controls and Validation CAPAs. 

• Participate in Customer/Agency Audits and Inspections as required. 

• Participate in on-the-job training programs for Validation staff and provide training as needed. 

• Uphold data integrity principles in accordance with Lonza policies. Proactively evaluate, identify, and improve data integrity processes. 

• Perform any other tasks as assigned by the manager. 

Key Requirements: 

• Bachelor’s Degree with exposure to the Biopharmaceutical industry.

•  5-10 years of relevant work experience in Validation, Quality, or Manufacturing units within the pharmaceutical/biotech industry. 

• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP, and ICHQ7). 

• Strong knowledge and experience with the practical and theoretical requirements of a validation program in a GMP facility. 

• Excellent oral and written communication skills. 

• Meticulous and detailed approach to work. 

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.