Process Operation Specialist

United States, Walkersville (Maryland)

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.

We are hiring a Process Specialist to join our team in Walkersville, Maryland.  This individual will be responsible for leading or representing manufacturing in process optimization projects. They will liaise with QC, Document Control and Quality on records/documents to ensure the requirements for manufacturing and release of products will be met.

Key responsibilities:

  • Leverage technical expertise to optimize production documentation.  Drive creative thinking beyond the boundaries of existing industry practices and client mindsets.
  • Responsible for the ordering/review of Media documentation/batch records and timely flow from production to Quality Assurance.
  • Lead and/or represent manufacturing on functional sub-teams where appropriate.  Provide expertise and operational support to projects.
  • Work closely with manufacturing staff to ensure appropriate implementation of process/document changes.  Provide training related to process changes or corrective actions, as appropriate.
  • Act as an Operational Excellence knowledge resource to the manufacturing team, coaching others in the philosophy, methods, tools and techniques of process improvement.  Plan, lead, drive and execute continuous improvement projects that increase throughput, provide favorable P&L impact, and improve organizational scalability using Lean/DMAIC approach.
  • Perform investigations, including root cause analysis for adverse events.  Work with area managers and SMEs to determine corrective and preventative actions for root causes identified during investigations.  Perform effectiveness checks to ensure non-recurrence of adverse events.
  • Revise SOPs, Batch Records or other documentation as needed.  Manage change requests and/or equipment utility change controls.
  • Perform other duties as assigned.

Key requirements:

  • High school diploma or equivalent.
  • Lean Six Sigma Yellow Belt certification preferred.
  • Strong manufacturing or technical skills required.
  • Questioning attitude to drive problem solving.
  • Ability to collaborate with cross-functional teams.
  • Ability to communicate effectively to share learning and provide training to manufacturing.
  • Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
  • Must have the ability to comprehend process flow and identify factors which influence the process.
  • Must be able to read and follow defined SOPs and policies, work independently and as part of a team on various manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with management. 
  • Must be proactive, action oriented, and have the ability to adapt to a change. 
  • Must be able to identify and flag corrections/problem records in a timely manner to keep deliverables on track. 
  • Strong communication skills both verbally and written. 

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: R38424