Project Engineer - Cell and Gene Therapy at Lonza Biologics Inc. in Portsmouth, New Hampshire

Job Description:

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 you to be part of.

Location: Portsmouth, NH Hybrid

The Project Engineer role supports ongoing Lonza operations by providing technical leadership as it relates to manufacturing and process systems. The role acts as a technical resource to operations customers to ensure that equipment and facilities are designed, operated, and maintained to meet production needs. Responsibilities of the role include implementation of engineering projects to support manufacturing requirements.

Key Responsibilities:

Manufacturing Support

• Develop technical knowledge on manufacturing equipment and processes

• Manage resolution of major equipment breakdowns and quality issues in the suites

• Provide SME support to Manufacturing and other departments for the design and operation of process equipment

• Conduct troubleshooting and technical analyses on manufacturing equipment and processes including PI data analyses, CIP/SIP circuit review, MOC analyses, flow path analyses, etc.

• Assist with tech transfer of new processes into the facility

• Modify/develop preventative maintenance plans and create spare parts

• Complete change request lot assessments to support lot release

• Participates in IPT/JPT meetings and customer ad hoc meetings as engineering SME

• Represents group at Manufacturing Engineering DMS meetings (this includes covering ALT and FLT meetings as lead for team).

• Participates in audits and inspections as engineering SME.

• Able to mentor/direct plant engineers to use and understand workings of quality and business systems within the organization.

• Responsible for identifying, managing and prioritizing own work load effectively with minimal supervision.

Supervising (as required)

• Assign work to direct reports including new projects and initiatives, prioritize work based on business needs, impact to quality and safety, and employee development.

Projects

• Planning, leading and execution of plant projects involving complex equipment changes and significant process improvements including lump sum capital projects

• Plan, execute and lead commissioning protocols (installation, operation, CIP/SIP, wet testing)

• Own change requests and complete change request tasks to support project completion

Deviations / RCAs

• Assist the Quality department with deviation investigations

• Performs Engineering review/approval of deviations

Documentation

• Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, error prevention activities, etc.

• Complete engineering review/approval of batch records, deviations, commissioning protocols, and validation protocols

Training

• Remain up to date on all assigned training activities including SAP Learning Portal (>90%), ComplianceWire (no overdue), iComply (no overdue), and QSMRT (attend all sessions)

• Qualified trainer within department

Perform other duties as assigned

Key Requirements:

Bachelor of Science in Engineering discipline

5+ years related work experience

Proficient with Microsoft Office Suite with focus on Outlook, Word, PowerPoint and Excel. Proficiency with OSI PI is preferred.

Strong, collaborative communication skills

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.