Principal Process Engineer, LNP

CRISPR Therapeutics AG•Framingham, MA

47d•$172,000 - $185,000•Onsite

About The Position

The 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 successful candidate will be creative, team oriented and have hands on experience in Engineering support of cGMP manufacturing operations and design of new processes, and a strong grasp process equipment within a multi-product, FDA regulated, cGMP facility. The ideal candidate will participate in all levels of design, startup, and operations including on the floor support of systems and issues. They will serve as a consultant to management on major engineering challenges pertaining to policies, plans, and objectives and will report directly to Head of Process Engineering.

Requirements

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

Nice To Haves

Experience with Kneat and Blue Mountain CMMS

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