Manufacturing Project Specialist

United States, Portsmouth (New Hampshire)

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 Manufacturing Project Specialist is responsible to support manufacturing projects in partnership with the Manufacturing Leadership Team and participate in projects cross-functionally across the site. This person will work closely with Manufacturing Management to support the achievement of department goals, interdepartmental readiness and batch release requirements, and maintain due dates to support the on time release of batches. The Manufacturing Project Specialist has responsibility for the planning, preparation, implementation and delivery of projects assigned. The Project Specialist supports by working cross-functionally and in collaboration with internal support departments, customers and Manufacturing suites to develop or update procedures or steps, identify and escalate risks, communicate changes and plan for execution. The Project Specialist is responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time performance.  The individual will manage a collection of projects in addition to ensuring Manufacturing CAPA closures, Change Controls and Low Minor deviations are progressing to the agreed upon timelines. In addition to managing the timelines of the Manufacturing Quality Documents, the Project Specialists will be assigned large scope CAPA to own. The individual will be assigned Laboratory Investigation Reports perform Validation Protocol Review and various tasks to support Lot Release Requirements and continued production.

Key responsibilities:

  • 40%Own and manage Mfg. process specific change controls, planned deviations and CAPA’s. 
  • 30%Drive and own improvement projects that support KPI’s, with a focus on cost, innovation, on-time delivery and quality.
  • Responsible for setting clear timeline for  project initiation
  • Being accountable  for proposed timelines
  •  There is potential in Involvement  in batch record review documentation review,
  • Perform validation protocol review
  • Working directly with manufacturing to understand continuous improvement both on supervisors and management level
  • Responsible for inventory ordering

Key requirements:

  • BS in Life Science
  • Perform CAPA and Deviation checks
  • Use change controls as necessary
  • Engage in manufacturing specific projects
  • System ownership for specific QC analytical equipment

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: R31830