Manufacturing Specialist - Design/Implementation/Establishment

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 in partnership with the Manufacturing Leadership Team and cross-functionally across the site. This person will work closely with Manufacturing Management to support the interdepartmental requirements and maintain due dates. The Manufacturing Project Specialist has responsibility for the planning, 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. 

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.

*This position is set to report to work Monday - Friday 8:00 am- 5:00 pm*

Key Responsibilities

  • Own and manage Mfg. process specific change controls, planned deviations and CAPA’s. 
  • Drive and own improvement projects that support KPI’s, with a focus on cost, innovation, on-time delivery and quality. Manage projects from concept to completion; create and manage project plan, work cross-functionally to ensure right first time and provide adequate training to impacted areas.
  • Generate and Manage Metrics
  • Completion of Laboratory Investigation Reports. Perform Validation Protocol Review
  • Monitor Manufacturing CAPA due dates and support closure and extensions as needed

Key Requirements

  • AS/BS in Biotechnology, Biology, Chemistry, or equivalent preferred
  • Significant years of experience in Biotechnology, preferably Upstream and Downstream, or similar Manufacturing industry.
  • Excellent written (especially technical writing) and verbal communication skills.
  • Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.
  • Attention to detail and good investigation, problem solving and organizational skills.
  • Familiarity with SAP system an advantage
  • Ability to work in MS Word, Excel, PowerPoint

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: R31257
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