Commissioning Qualification Validation Lead mRNA
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.
We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic.
We are looking for a Commissioning Qualification Validation Lead to join our Engineering team at Lonza, Geleen. The Engineering Commissioning, Qualification & Validation Lead is responsible for supporting efforts that ensure all critical GMP regarding equipment, facility and/or systems are 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 Validation and is a resource to less experienced members.
- Lead the CQV team from the Engineering Department
- Ensure the building of new standards and ways of workings
- Ensure the qualified and validated status of the equipment portfolio
- Draft the necessary validation documentation such as IOQ and PQ protocols for the validation of GMP equipment, facility and/or systems within Lonza Netherlands.
- Execute 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.
- Reporting on executed validation activities according GDP and getting the reports approved in the Quality System.
- Schedule tasks to be performed according the prioritization aligned with the needs and the management.
- 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).
- Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations
- Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
- Perform other duties as assigned
- Bachelor degree in Science or Technical field
- Extensive experience within the Pharma industry
- 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.