OT CSV Engineer (m/w/d)

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.

Lonza in Verviers, Belgium is looking for an OT CSV Engineer (m/w/d).

Key responsibilities:
Write qualification/validation documents activities for the OT equipment/system/computer system during their entire lifecycle (e.g. GMP/Non-GMP classification, URS & SOP, Data Integrity risk assessment, new OT equipment qualification/modification/planned revalidation, decommissioning validation activities.)

Perform OT Quality and Validation roles in the Change Control system to assure the changes are implemented following the established procedures.

Management and follow-up the day-to-day quality activities (Change Control, Deviations, Global Observations, CAPA, others.) and participate to the quality meeting to represent the OT department.

Performs audit trail´s data integrity risk assessments as per current policies.

Act as OT Quality Specialist (SME and Quality point of contact) during project implementation.

Ensure the compliance of the local qualification/validation activities

with Lonza Corporate requirements/standards/current regulatory requirements.

Maintains appropriate independence to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities.

Manage Quality documentation of OT department with the help of Internal OT System Admin expert. (Write/Update/Withdrawn SOP, Procedures, Forms, Test script, Memo, etc…)

Handle the Role of Date Integrity Leader of Lonza Verviers and represent the site for all Data Integrity Aspect.

Key requirements:
Bachelor’s / Master’s Degree in Biology, Chemistry, Microbiology or Engineering

Fluent in French, Business Fluent in English

Previous work experience in CSV (Computer System Validation) / Quality / Data Integrity

Strong organizational and time management skills to carry out multiple assignments

IT/Automation knowledge of hardware and software

Thorough understanding of regulatory requirements for equipment/system/computersystem qualification; interpretation and application of US and EU GMPs

Strong Communications 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.

Reference: R43517