Senior Project Manager, MES

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 Portsmouth, is looking for a Senior Project Manager, MES to support the Automation & Controls and MES group in Portsmouth, NH.

POSITION:                 Sr. Project Manager, MES

JOB LOCATION:      101 International Drive, Portsmouth, NH 03801[and various unanticipated locations throughout the U.S.; may work from home]

Sr. Project Manager, MES needed by Lonza Biologics, Inc. in Portsmouth, NH [and various unanticipated locations throughout the U.S.; may work from home] to be responsible for leadership and coordination of cross functional teams consisting of internal customers such as manufacturing, MSAT, materials, quality control and quality assurance to properly identify design needs. Work on development and lifecycle support of standard global Manufacturing Execution Systems (MES) library objects. Collaborate with multiple sites for change request prioritization and execution. Ensure MES project execution including recipes, system interfaces, and data historization are aligned with global standards. Oversee technical transfer process and ensure that eBR records are constructed per best practices. Responsible for general management and oversight of the MES software documentation effort. Assist with development of project schedule and assure that software development, MES Recipe configuration, and validation efforts adhere to plan. Direct and manage activities of technical staff on URS/FRS generation, software configuration, and coding. Support project commissioning and startup activities. Assist with Computer Systems Validation (CSV) activities including validation plan, risk assessment, protocols, test protocols, and change requests. Understand and comply with 21 CFR Part 11, IQ7 and equivalent regulations. Provide routine project management updates in accordance with procedures. Work on project closure activities involving completion of technical close-out reports and summary of assets in accordance with financial recognition requirements. Provide technical leadership and direct support in the execution and delivery of the Manufacturing Execution System (MES) for large capital projects. Coordinate and manage project activities to meet scope, schedule, budget, safety, and quality requirements. Work with MES Center of Excellence (CoE) to ensure alignment with core standards. Design and operate MES into Biopharmaceutical facilities, both manufacturing and supporting systems including cGMP manufacturing, pilot plant, and laboratories. Work on MES systems. Work on project management and coordination associated with the execution of capital projects in an industrial environment. Apply experience for MEF project leadership by working on management and coordination of MES engineers, consultants, vendors, and contractors.           

MINIMUM REQUIREMENTS: Requires a Bachelor’s degree, or foreign equivalent degree, in Electronic Engineering, Computer Science, Chemical Engineering, or Biomedical Engineering and 5 years of progressive, post-baccalaureate experience in the job offered, or 5 years of progressive, post-baccalaureate experience in a related occupation designing and operating MES into Biopharmaceutical facilities, both manufacturing and supporting systems including cGMP manufacturing, pilot plant, and laboratories; working on MES systems; working on project management and coordination associated with the execution of capital projects in an industrial environment; and applying experience for MES project leadership by working on management and coordination of MES engineers consultants, vendors, and contractors.

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,