Project 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.
The Project Engineer is responsible to ensure all critical GMP regarding equipment, facility and/or systems are designed din accordance to GMP, validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The specialist works closely with Operations, Quality Assurance, our clientele, and regulatory bodies with scientifically sound, documented evidence that our systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment. At this level the specialist must possess a full grasp of the duties of Engineering / Validation and is a resource to less experienced members.
Lead the Project Team for technical aspects
Ensure the qualified and validated status of the equipment portfolio for the project based on GMP and state of the art design
Be responsible for the design and the integration of the equipment and facility
Support validation and re-qualification activities, including CSV activities when applicable, to ensure GMP equipment, facility and/or system is continuously maintained in a validated state.
Ensure planning and execution of the commissioning qualification and validation activities according GDP and getting the reports approved in the Quality System.
Perform change control assessments for GMP equipment, facility and/or system and associated validation activities to ensure compliance with regulatory requirements.
Demonstrate a thorough understanding of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment. Develop validation protocols from Validation plans (where/as applicable).
Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
Minimum Bachelor Degree in Science or Technical
Knowledge of GMP’s and regulations
Experience in the field of CSV (Computer System Validation)
Experience with Trackwise, SAP, Document Management System preferred
Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams
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.