Mfg Process Specialist 2

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 Process Specialist II is responsible for leading or representing manufacturing in process optimization projects, as well as in facilitating batch release. They will liaise with F&E, MSAT, R&D and Quality on projects to ensure the requirements for manufacturing will be met. They will be responsible for implementing new or improving existing equipment and processes in the manufacturing areas.  In addition, they may perform investigations for adverse events using root cause analysis tools and collaboration with SMEs/persons involved and will support batch record reviews as needed.

The individual will manage a collection of projects in addition to ensuring Corrective and Preventative Action (CAPA), 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:

  • Own and manage Mfg. process specific change controls, planned deviations and CAPA’s. 
  • Monitor Manufacturing CAPA due dates and support closure and extensions as needed
  • Work with area management and Subject Matter Expert (SMEs) to assess production process and equipment issues and provide solutions. Provide key data and updates to management.
  • Leverage technical expertise to optimize production process and/or conduct investigations to determine root cause(s).  Drive creative thinking beyond the boundaries of existing industry practices and client mindsets.
  • Focus on return to service and tech transfer activities for new and returning FFM products.  Will be responsible for creation/updating of process design, process validation, device master records, and QACS documents for required products.
  • 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/equipment 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:

  • AS/BS in Biotechnology, Biology, Chemistry, or equivalent
  • High School Diploma or Equivalent may be considered with relevant experience
  • Experience in Biotechnology, preferably Upstream and Downstream, or similar Manufacturing industry. (Strong experience without AS/BS will be considered)
  • 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.
  • 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.
  • Must be proactive, action oriented, and have the ability to adapt to a change. 
  • Must have 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: R31260
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