Sr Process Engineer

United States, Lexington (Massachusetts)

Today, Lonza is a global leader in life sciences operating across three 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.

The Sr Process Engineer is responsible for supporting site drug substance and drug product operations by ensuring that equipment and related processes (including automation) are designed and operating to meet the requirements of a regulated manufacturing site. Increase equipment/systems reliability and support the development or improvement of the exosome manufacturing processes at the Lexington, MA facility.

Key Accountabilities:

  • Deliver 24x7x365 support (as required) to manufacturing operations by troubleshooting equipment, systems, and processes to resolve issues that may arise during manufacturing campaigns.
  • Provide process engineering support for ongoing production operations and new equipment/process introductions.
  • Support equipment or processes; including bioreactors, biosafety cabinets, mixers, cell counters, incubators, process gases, pump system, filling process, and room environmental conditions
  • Provide and assist in training, mentoring and development plan for site technicians, specialists, engineers and other operations personnel.
  • Effectively communicate progress and opportunities (i.e. roadblocks) to stakeholders. 
  • Equipment/Systems - Owner, Administrator
  • Perform as owner for engineering equipment and systems.
  • Perform as system administrator for manufacturing equipment and systems.
  • Monitor and trend equipment and process issues to identify and develop corrective and preventative solutions.
  • Increase process control by utilizing automation concepts.
  • Recommend and support implementation of improvements to maintenance instructions including Job Plans, Spare Parts Lists, SOPs, and others.
  • Responsible to report process improvements, develop metrics and perform equipment failure analysis.
  • Provide engineering solutions and use Lean design principles to maximize process efficiency and improve quality performance of the assigned processes.  •    Apply continuous improvement methodologies to ensure process reliability. Quality Systems
  • Own or support review/approval of Change Control Requests, Deviations/Investigations, Corrective/Preventative Actions, and Commissioning Test protocols.  
  • Support review/approval of Qualification/Validation protocols and related documentation, including project/master plan and assessments.
  • Support internal and external audits and regulatory inspections.
  • New Equipment/Process Introductions 
  • Evaluates and utilize technology to incorporate innovation into process designs. 
  • Interact with internal/external customers (i.e MSAT) and evaluate process requirements to ensure the facility and equipment capabilities can accommodate.  
  • Develop requirements and specifications for new equipment and systems; including modification to existing equipment/systems, and process improvement initiatives.

Key Requirements:

  • Bachelor’s Degree, preferably in science or engineering. Master’s Degree in similar field preferred. Automation Professional Certification desired.
  • Certifications (incl. professional qualifications) i.e. ACCA, GPHR, CIPS, PgMP
  • Pharmaceutical or Biotech Manufacturing Processes experience 
  • GMP, FDA Regulated Industry Experience  
  • Adapts thinking and behavior to support change
  • Takes personal responsibility for promoting change in his/her area 

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 it is 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: R40614