Computerized System Validation Engineer 1

Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five 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.

Lonza is currently looking to hire an CSV Engineer 1, Validation. This remarkable opportunity allows you to join an outstanding team, where your work will directly contribute to detailed biotech manufacturing processes. In this role, you will support the validation of computerized systems in a Good Manufacturing Practice (GMP) pharmaceutical environment, ensuring compliance with regulatory requirements and standard methodologies. You will work closely with multi-functional teams, including Engineering, Quality, Automation, and IT, to validate systems that support manufacturing, laboratory, and business processes. Our ambitious vision is to successfully implement innovative solutions that make a positive difference. If you have the determination to inspire change, this is the role for you.

**Key responsibilities**:

- Develop, complete, and detail computerized system validation (CSV) protocols (IQ, OQ, PQ) and reports.
- Support day-to-day validation activities, ensuring alignment to approved Validation SOPs, Plans, and Policies.
- Assist in investigating and closing discrepancies and deviations related to system validation.
- Collaborate with vendors and Engineering teams to evaluate new equipment or modifications, ensuring validation protocols demonstrate compliance with user and project requirements.
- Work closely with End-Users, Quality, and Engineering functions to ensure validation activities are completed as planned.
- Review and approve engineering and validation documentation related to commissioning and qualification activities.
- Participate in the Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
- Assist Validation activities related to validation of facility, equipment utility, cleaning, and sterilization
- Support change control activities, ensuring accurate validation assessments and documentation.
- Assist in customer and regulatory agency audits/inspections, providing validation documentation and responses as needed.
- Perform additional duties as assigned by the Validation Lead or Manager.

**Key requirements**:

- Strong interest in computerized system validation (CSV), automation, and regulatory compliance within the pharmaceutical industry.
- Basic understanding of GMP regulations, 21 CFR Part 11, GAMP 5, and data integrity principles (preferred).
- Proficiency in understanding and interpreting user documentation, system specifications, and validation protocols.
- Strong analytical, problem-solving, and organizational skills.
- Excellent communication skills and ability to work in a team-oriented environment.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Willingness to learn and adapt in a fast-paced, regulated industry.

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.