CSV Engineer (m/f/d)

CSV Engineer (m/f/d)

Location: Stein, Switzerland
Company: Lonza
Employment Type: Full-Time

Join Lonza, a global leader in life sciences, and contribute to impactful pharmaceutical projects. We are seeking a CSV Engineer to support the commissioning, qualification, and validation (CQV) activities of cutting-edge systems in Stein, Switzerland.

Responsibilities

• Oversee and execute CSV deliverables and tests for Delta V software development, ensuring compliance with Lonza SOPs and regulatory guidelines.
• Develop, review, and manage CSV documentation throughout the project lifecycle.
• Serve as the subject matter expert (SME) for CSV activities, ensuring alignment with Lonza's CQV standards.
• Collaborate with cross-functional teams, including Process Engineers, QA, Automation, and Project Managers, to deliver successful outcomes.
• Execute validation testing (FAT/SAT) and ensure seamless integration of systems into the Lonza environment.
• Provide technical expertise, address compliance gaps, and support inspections as the CSV representative.

Requirements

• Bachelor's degree in Engineering, Applied Sciences, or a related technical field.
• Minimum of 5 years in CSV/CQV, with expertise in Delta V DCS and large pharmaceutical projects.
• Familiarity with regulated environments (EMA/FDA) and experience in biologics or chemical manufacturing.
• Proficiency in ISPE GAMP5 and ASTM guidelines.
• Hands-on experience in vertical integration, data management, and validation testing (FAT/SAT).
• Strong analytical and organizational abilities with a proactive, solution-driven mindset.
• Fluent English is mandatory; German is an advantage.

Take this opportunity to join Lonza and make a difference in the life sciences industry!

Apply now and shape the future with Lonza.