Process Expert

United States, Walkersville (Maryland)

Process Expert

Location: This position is based in our Walkersville, MD office, with Salisbury, MD also serving as a site location. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

What You Will Get

The full-time base annual salary for this remote position is expected to range between $80,000 to $128,000. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).
  
  

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What You Will Do

• Operate and provide technical oversight of aseptic isolator vial filling lines across multiple products and vial sizes, ensuring compliance, efficiency, and best practices.
• Serve as a technical process expert, leading and supporting complex manufacturing projects using scientific and statistical methodologies.
• Drive process development, scale-up, and validation activities, including FAT, SAT, PQ, SOP development, recipe generation, and regulatory validation milestones.
• Lead process optimization initiatives and troubleshoot manufacturing and equipment issues through hands-on shopfloor support and data-driven analysis.
• Conduct and lead investigations related to deviations, complaints, and process failures; identify root causes and implement corrective and preventive actions (CAPAs) within TrackWise.
• Ensure technical batches generate robust process knowledge by testing and evaluating critical process parameters and variables.
• Maintain inspection readiness and support internal and external audits in a regulated GMP environment.
• Develop and deliver training for new processes, products, and equipment to ensure consistent operational excellence.
• Collaborate cross-functionally with manufacturing, quality, engineering, and project teams to meet production timelines and business objectives.
• Support implementation of process and equipment changes, ensuring effective knowledge transfer and operator readiness.
• Drive continuous improvement initiatives that enhance quality, efficiency, and innovation beyond standard industry practices.
  
  

What We Are Looking For

• Minimum of 5 years of relevant work experience, preferably within sterile manufacturing or a regulated pharmaceutical/biotech environment.
• Demonstrated questioning mindset with a strong ability to drive effective problem solving and root cause analysis.
• Self-motivated and results-oriented, with the ability to work independently and take ownership of deliverables.
• Strong collaboration skills with the ability to work effectively across cross-functional teams.
• Excellent communication skills, with the ability to share learnings, deliver training to manufacturing teams, and interact effectively with multiple interfaces across the organization and on the shopfloor.
• Proven technical and process understanding within a sterile manufacturing environment.
• Solid knowledge of GMP requirements, quality systems, and SOP execution in a regulated setting.
• Strong team orientation with the ability to contribute positively to a collaborative work environment.
• Structured, proactive, and organized working approach with strong attention to detail.
• Proficient IT skills: experience with SAP and/or MES systems is considered an asset.
  
  

About Lonza

At Lonza, our people are our greatest strength. With 30 sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Reference: R72397

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