Sr. MES Project Manager
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 Sr. MES Project Manager is responsible for providing technical leadership and direct support in the execution and delivery of the MES configuration for large Capital Projects within Lonza, including adherence to schedule and budgets, engineering design of new facilities (Basis of Design, Conceptual, and Detailed Design), and leadership of cross functional teams consisting of Internal Lonza customers such as Manufacturing, MSAT, Materials, Quality Control and Quality Assurance to properly identify design needs. This position will focus on delivery and oversite of MES recipes and configuration, i.e. Electronic Batch Records (eBR), Electronic Log Books (eLogs), Equipment Tracking (ET), and general configuration of the MES system.
- Responsible for providing technical leadership and direct support in the execution and delivery of the Manufacturing Execution System (MES) for large Capital Projects within Lonza.
- Leadership and coordination of cross functional teams consisting of Internal Lonza customers such as Manufacturing, MSAT, Materials, Quality Control and Quality Assurance to properly identify design needs.
- Oversee Technical Transfer process and ensure that eBR records are constructed per best practices
- Direct and manage activities of technical staff on URS/FRS generation, software configuration and coding.
- Construction, commissioning, startup activities
- Supervision and management of external MES engineering contractors and software vendors
- Coordinate and manage project activities to meet scope, schedule, budget, safety, and quality requirements
- General management and oversight to the MES software documentation effort
- Liaise where necessary with MES platform provider, engineering contractor, and equipment vendors on the lifecycle of document preparation, approval, coding, and delivery
- Candidate must have strong troubleshooting skills in support of startup activities
- Assist with Computer Systems Validation (CSV) activities: Validation Plan, Risk Assessment, Protocols, Test Protocols, Change Requests etc.
- Protocol management and execution of validation activities
- Provide routine project management updates in accordance with Lonza procedures
- Project Close-out activities involving completion of technical close-out reports and summary of assets in accordance with Lonza financial recognition requirements
- Bachelor’s Degree Required – candidate should have BS EE, Computer Science, ChemE, MechE or BioE or equivalent experience.
- Substantial experience with design and operation of Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories).
- Significant experience with MES systems desirable.
- Experience in project management and coordination associated with the execution of capital projects in an industrial environment
- Practical experience in the management and coordination of MES engineers, consultants, vendors and contractors.
- Capacity to deliver strong and effective project engineering skills on capital projects
- Strong understanding of the fundamentals of large scale commercial mammalian cell culture processing.
- Experience with design and operation of Manufacturing Execution Systems (MES), preferably Emerson Syncade
- Experience with MES integration with Enterprise Resource Planning (ERP, preferably SAP) and Laboratory Information Management Systems (LIMS) systems
- Experience with historians, preferably OSISoft PI.
- Understanding of the design of Process Control System (PCS), MES and associated Network Architectures
- Understanding of system hardware design for PCS and MES
- Team player with exceptional customer service skills, integrity and ability to interact with all levels of personnel.
- Requires strong attention to detail and analytical skills as well as problem analysis and resolution.
- Ability to handle multiple projects (5-10) simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards.
- Ability to evaluate solutions and recommend action based on meeting scope, schedule, and budget
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 it is 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.