Senior Aseptic Filling Validation Specialist

United States, Walkersville (Maryland)

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.

The Aseptic Filling Cleanroom Validation Specialist is responsible for supporting all activities associated with qualification and the required documentation with regard to Aseptic Filling validation procedures utilized at Lonza, Walkersville while ensuring these meet the acceptance criteria and comply with regulatory guidelines. The specialist must possess a full grasp of the duties of Validation and is expected to serve as a model and resource to less experienced staff on the team. Additionally, the Specialist will support the team in the manager’s absence and may be assigned special projects while maintaining their regular duties.

Key responsibilities:

  • Develop complex aseptic processing cleanroom qualification protocols including Heating, Ventilation, and Air Conditioning (HVAC) qualification, Environmental monitoring, and media fill protocols for execution.
  • This role also develops protocols for qualification of automated, semi-automated and manual aseptic filling processes.
  • Schedules and tracks Aseptic protocol executions, includes coordinating with scheduling and manufacturing.
  • Protocol close-out activities including drafting of summary reports, obtaining sample results via Laboratory Information Management Systems (LIMS), maintaining execution tracker and discrepancy reports generation.
  • Work to identify efficiencies in Validation program approach.
  • Work to apply lessons learned and stay informed of industry regulatory changes as it applies to Aseptic Filling validation.
  • Perform assigned Quality Systems activities including: Document Management System (DMS), Information Management System (ProCal) and Trackwise system (Change Control, Deviations, CAPA, etc.).
  • Act as point person for customer communications as assigned
  • Participate in Audits and Inspections
  • Provide SME level expertise

Key requirements:

  • Bachelors Degree in Science or Technical Discipline
  • Adherence to cGMPs is required at all times during the manufacture of APIs.  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.
  • Validation background in GMP environment

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: R22446