Project Engineer, Cell & Gene Therapy
United States, Portsmouth (New Hampshire)

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 Project Engineer role supports ongoing operations at the Portsmouth, NH site through technical assistance as it relates to manufacturing and process systems.  The focus of the role is on ensuring manufacturing equipment and facilities are operating as intended while managing a variety of projects to meet the requirements for biopharmaceutical manufacturing and to drive improvements. Responsibilities of the Project Engineering function include both tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.

This Project Engineer will support the Cell Therapy Asset. This engineer will help support; tech. transfers of new customers to Lonza, ongoing operations, construction projects and more. Roles and responsibilities are listed in more details below.

Thank you for your interest!

Key Responsibilities:

  • Safety leadership by example
  • Support asset by leveraging technical knowledge on manufacturing equipment and processes.
  • Responsible and accountable for resolution of all major equipment breakdowns and quality issues.
  • Provide support for the design and operation of process equipment
  • Conduct troubleshooting and root cause analysis on manufacturing equipment and processes
  • Act as process engineering lead for tech transfer of new processes into the facility
  • Modify/develop preventative maintenance plans and create spare parts. Sustain and improve maintenance program for the asset.
  • Participates in audits and inspections as engineering SME
  • Manage engineering contractors to augment Lonza engineering staff
  • Planning and execution of plant projects involving complex equipment changes and significant process improvements including capital projects
  • Execute commissioning protocols (installation, operation, CIP/SIP, wet testing)
  • Own change requests and complete change request tasks to support project completion
  • Assist the Quality department with deviation investigations
  • Owns and executes completion of CAPA actions, participates/Leads quality risk assessments
  • Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures
  • Review of batch records, deviations, commissioning protocols, and validation protocols
  • Initiate updates to Engineering documents including engineering drawings
  • Technical owner of P&IDs for process equipment
  • Balances priorities effectively to achieve milestones and timelines.

Key Requirements:

  • Bachelor’s degree required. Preferred areas of study: Computer Science, Information Technology or an applicable Engineering discipline.
  • 5+ years of relevant experience
  • Substantial pharmaceutical/biotechnology experience (or equivalent)
  • Experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems.
  • Experience with control systems (PLC, DCS, Loop controllers) desirable.
  • Project management and coordination experience associated with the execution of capital projects in an industrial environment in required.
  • Practical experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors is required.
  • Proficient with Microsoft Office Suite with focus on Outlook, Word, PowerPoint and Excel. Experience with OSI PI is preferred.
  • Ability to handle multiple projects simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards.
  • A solid understanding of design principles and standards within Biopharmaceutical facilities.

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: R60391