Principal Process Engineer, LNP

Role Summary

Principal Process Engineer is responsible for design, construction, commissioning and technical support of process systems at the state-of-the-art cell therapy manufacturing facility being built in Framingham, MA. The role requires hands-on engineering support of cGMP manufacturing operations and design of new processes within a multi-product, FDA regulated facility. The candidate will participate in all levels of design, startup, and operations, including on-the-floor support, and will report to the Head of Process Engineering.

Responsibilities

• Design, specification, and selection of single use equipment systems
• Generate system user requirement specifications (URS)
• System SME representative in design reviews
• Support automation and monitoring systems integration
• Generate facility capacity models and design the development of COGs models
• Provide and delegate technical support of Commissioning & Qualification activities (approval of protocols and reports)
• Technical guidance SME and deliver analysis for the resolution of equipment related deviations and investigations
• Lead implementation of process improvement projects through change control
• Co-author department procedures and specifications

Qualifications

• Required: Bachelor of Science in Chemical, Mechanical, or Bio-Engineering with 15+ years of relevant experience or PhD with 8+ years of experience
• Experience with specification and implementation of single use systems (tangential flow filtration systems a plus)
• Excellent attention to detail and ability to manage multiple priorities with aggressive timelines
• Strong leadership, interpersonal communication skills, and ability to work with internal cross-functional teams and external partners
• Proficient in applying good engineering practices, industry guidance, and regulatory requirements
• Creative problem solver and decision maker

Skills

• Single use equipment systems
• Automation and monitoring systems integration
• Process engineering in cGMP environments
• Commissioning & Qualification activities
• Deviation investigations and change control

Education

• Bachelor of Science in Chemical, Mechanical, or Bio-Engineering (minimum)
• Advanced degrees beneficial depending on experience

Additional Requirements

• On-site work only at manufacturing and lab facilities