Posted

30+ days ago

Location

Walkersville, MD

Description

 

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

Manages the operational activities of assigned manufacturing projects with overall responsibility of manufacturing execution with regards to safety, quality and on-time-in full delivery. Strong focus on continuous improvement and capacity optimization.

Key responsibilities:

  • Leads multi-disciplinary project teams as Functional Lead for all LAL manufacturing aspects of assigned area between manufacturing and support services (F&E, MSAT, QA, VAL, SC, etc.) for LAL

  • Responsible for continuous improvement taking the established operational excellence methods into account. Ensures a high level of technical and process standardization within the production plant

  • Represents Manufacturing as CAPEX project lead in maintenance and growth engineering projects by leverage technical expertise to optimize manufacturing processes

  • Work with area management and SMEs to assess production process and equipment issues and provide solutions. Provide key data and updates to management.

  • Manages all cGMP equipment in LAL such as filling machines, labeling machines, depyrogenation equipment, centrifuges, lyophilizers, etc.

  • Responsible to prepare and execute Quality and Safety risk analysis for the assigned products and the implementation and control of defined measures. 

  • Represent manufacturing on functional sub-teams where appropriate.  Provide expertise and operational support to projects (FAT, SAT, IQ/OQ/PQ, etc.).

  • Is responsible for the documentation of the processes and process Know-How with the corresponding reports according to the asset- or product specific requirements incl. SOP or other documentation as needed

  • Represent LAL Manufacturing unit during customer audits and visits

  • Perform equipment related investigations, including root cause analysis for adverse events (deviations).  Work with area managers and SMEs to determine corrective and preventative actions (CAPAs) for root causes identified during investigations.

  • Perform effectiveness checks to ensure non-recurrence of adverse events.

Key requirements:

  • Master’s Degree in Engineering, Biotechnology, or Science background

  • Must have Lean Six Sigma

  • Ability to collaborate with cross-functional teams

  • Drive for quality focused solutions. Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

  • Questioning attitude to drive problem solving/troubleshooting

  • Critical risk based thinking

  • Technical writing and report generation

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.