Manufacturing Execution Systems (MES) Business Analyst
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 Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in the Facilities & Engineering group. The Lonza Houston site is undergoing an effort to digitalize the operation by the implementation of a Manufacturing Execution System (MES). The MES Business Analyst will focus on supporting internal customers who use MES and providing technical solutions for the Houston site. This role is also responsible for leading and assisting in performing tasks associated with the creation, integrating, administration, maintenance, and upkeep of the MES system.
- Work closely with MES manager, system users, automation engineers and process owners to create, develop and revise MES recipes in a timely manner.
- Configure production recipes using a library of objects.
- Conduct troubleshooting on all related systems and provide ongoing end user support. Some off-hours coverage and support responsibilities are required.
- Assist in fulfilling requirements of quality records such as process change controls, CAPA, and deviations.
- Manage MES master data like Products, Locations, Equipment, Materials.
- Author training material and execution of training related to MES.
- Create/modify label templates.
- Perform and execute validation of recipes (IQ, OQ, PQ).
- Creation/modification of SOP required for MES deployment.
- Update of batch records required for the MES deployment.
- Support floor activities as required to bring running records to successful process conclusion.
- Work closely with Process Engineer, Automation Engineer and MES Analysts to develop and revise controls logic, batch records and other MES systems integration in a timely manner.
- Support Production via the Helpdesk, assisting with production issues.
- Perform System administration tasks, i.e. account creation and maintenance, system integration, back end infrastructure monitoring, system maintenance, and other tasks as assigned. Receives minimum guidance from other colleagues on advanced troubleshooting and tasks.
- Develop technical knowledge on manufacturing equipment.
- Support resolution of equipment breakdowns and quality issues in the suites with assistance.
- Perform other duties as assigned.
- Certificate/ ASC/ BS in science related discipline preferred
- Advanced experience in biotech work environment preferred
- Prior exposure working in an FDA regulated environment preferred
- Relevant experience in cGMP environment
- Prior knowledge and experience of Automation/MES systems development and integration preferred.
- Some prior knowledge of Biotech manufacturing Automation and/or MES software preferred
- Ability to communicate to internal, external personnel and stakeholders
- Ability to secure relevant information and identify key issues and relationships from a base of information
- Ability to work in a fast paced environment
- Relate and compare data from different sources and identify cause and effect relationships
- Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions
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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.