Process Expert, Endotoxin Testing

Lonza-posted 8 months ago
$74,000 - $118,000/Yr
Full-time • Mid Level
Walkersville, MD
Professional, Scientific, and Technical Services
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Today, Lonza is a global leader in life sciences operating across five 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. Lonza Walkersville is seeking a Process Expert - Endotoxin Testing to join our Manufacturing team. This highly visible role will serve as a technical leader in aseptic manufacturing operations, specifically supporting endotoxin testing processes. The ideal candidate will bring deep scientific expertise, hands-on shopfloor experience, and a proactive, problem-solving approach to drive process optimization, support GMP compliance, and enhance operational performance. This is an exciting opportunity to contribute to a dynamic team committed to delivering high-quality biologics while upholding the highest safety and compliance standards.

  • Operate and oversee aseptic isolator vial fill lines for various product types and vial sizes, ensuring efficient and compliant production.
  • Lead cross-functional teams on sophisticated technical projects, applying knowledge to meet manufacturing goals.
  • Support validation activities including FAT, SAT, PQ, SOP creation, and recipe development; drive key milestones for growth initiatives.
  • Complete process improvements, troubleshoot equipment and manufacturing issues, and provide shopfloor support alongside operators and SMEs.
  • Lead investigations into process deviations and customer complaints; analyze data to identify root causes and implement effective CAPAs.
  • Maintain GMP compliance and inspection readiness; support both internal and external audits.
  • Develop and deliver process and product training to support onboarding and continuous learning within manufacturing.
  • Drive innovation and continuous process improvements by leveraging technical knowledge and creative problem-solving.
  • Serve as a manufacturing representative in sub-teams to ensure alignment and operational readiness for process or equipment changes.
  • Contribute to efficient process optimization while ensuring all operations are conducted in a safe, compliant manner.
  • Bachelor's degree in a scientific or technical field or equivalent experience.
  • At least 5 years of experience in sterile GMP manufacturing, with hands-on exposure to automated isolator fill line technology.
  • Confirmed ability to troubleshoot and optimize manufacturing processes.
  • Deep understanding of GMP regulations, SOP execution, and quality systems.
  • Comfortable analyzing data using scientific and statistical tools.
  • Excellent collaboration skills with cross-functional teams.
  • Effective written and verbal communication skills; able to deliver training and interface with team members at all levels.
  • Familiarity with SAP, MES or equivalent experience, and other digital manufacturing tools is a plus.
  • Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.
  • Self-motivated, organized, and diligent to detail.
  • Medical and dental coverage
  • 401k plan
  • Life insurance
  • Short-term and long-term disability insurance
  • Employee assistance program
  • Paid time off (PTO)
  • Performance-related bonus
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