Project Engineer - Cell and Gene Therapy

Lonza - Portsmouth, NH

Full-time - Mid Level

Portsmouth, NH

Professional, Scientific, and Technical Services

About the position

The Project Engineer role at Lonza is pivotal in supporting ongoing operations by providing technical leadership related to manufacturing and process systems. This position acts as a technical resource to ensure that equipment and facilities are designed, operated, and maintained to meet production needs, while also implementing engineering projects to support manufacturing requirements.

Responsibilities

• 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
• Participate in IPT/JPT meetings and customer ad hoc meetings as engineering SME
• Represent group at Manufacturing Engineering DMS meetings
• Participate in audits and inspections as engineering SME
• Mentor/direct plant engineers to use and understand workings of quality and business systems
• Identify, manage and prioritize own workload effectively with minimal supervision
• Assign work to direct reports including new projects and initiatives
• Plan, execute and lead 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
• Perform Engineering review/approval of deviations
• Review/revise Engineering and Manufacturing related SOP's, work instructions, and maintenance assessments/procedures
• Complete engineering review/approval of batch records, deviations, commissioning protocols, and validation protocols
• Remain up to date on all assigned training activities including SAP Learning Portal, ComplianceWire, iComply, and QSMRT
• Act as a qualified trainer within the department
• Perform other duties as assigned

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