MES Analyst, GMP Production

United States, Houston (Texas)

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 Analyst will focus on supporting internal customers who use MES.  This role is also responsible for assisting in performing tasks associated with the creation, maintenance, and upkeep of the MES system.

Key Responsibilities:

  • Work closely with MES manager, system users and process owners to develop and revise MES recipes in a timely manner.   

  • Configure production recipes using a library of objects.

  • Conduct basic 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 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 Automation and MES Analysts to develop and revise Controls Logic, batch records and other MES records in a timely manner.

  • Support Production via the Helpdesk, assisting with production issues.

  • Perform System administration tasks, i.e. account creation and maintenance, system maintenance, and other tasks as assigned. Receives some 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.

Key Requirements:

  • Bachelor degree preferred in a technical field and/or engineering. Combinations of education and experience considered, with Certificate

  • 5-7 years of experience implementing an MES system in a GMP regulated environment.  Previous Pharma/ Biotech production experience preferred.

  • Well versed with front-end infrastructure.

  • Experience with Rockwell, Honeywell or Werum MES systems highly desired.

  • Ability to provide overnight MES system support on a rotational basis.

  • Advanced communication skills.  Ability to manage stakeholder relationships.

  • Ability to work in a fast-paced environment

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. 

Reference: R47067