Process Expert, Endotoxin Testing (Biotech)
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.
Key Responsibilities:
Technical Operations & Oversight: Operate and oversee aseptic isolator vial fill lines for various product types and vial sizes, ensuring efficient and compliant production.
Project Leadership: Lead cross-functional teams on sophisticated technical projects, applying knowledge to meet manufacturing goals.
Process Development & Validation: Support validation activities including FAT, SAT, PQ, SOP creation, and recipe development; drive key milestones for growth initiatives.
Troubleshooting & Optimization: Complete process improvements, troubleshoot equipment and manufacturing issues, and provide shopfloor support alongside operators and SMEs.
Deviation & Complaint Management: Lead investigations into process deviations and customer complaints; analyze data to identify root causes and implement effective CAPAs.
Audit Readiness & Compliance: Maintain GMP compliance and inspection readiness; support both internal and external audits.
Training & Knowledge Transfer: Develop and deliver process and product training to support onboarding and continuous learning within manufacturing.
Continuous Improvement: Drive innovation and continuous process improvements by leveraging technical knowledge and creative problem-solving.
Cross-Functional Collaboration: Serve as a manufacturing representative in sub-teams to ensure alignment and operational readiness for process or equipment changes.
Budget & Safety Support: Contribute to efficient process optimization while ensuring all operations are conducted in a safe, compliant manner.
Key Requirements:
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.
We recognize that attracting, developing and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates. As required by law in this state, the quoted salary range for this on-site position is $74,000.00 – $118,000.00. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate's experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza's total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.
