Sr. Manufacturing Process Engineer

Cambridge, MA /
Manufacturing /
Full time
Company Summary
We are an exciting, fast-growing biotech company that has changed the rules for how liquids move. Viscous liquids are sticky, and they don’t flow easily—think ketchup, toothpaste, heavy oil, or paint. This creates a lot of waste and inefficiency and handcuffs the way we design. But not anymore. Invented at MIT, our liquid surface technology eliminates the friction between liquids and solids to help liquids flow with ease and enables breakthroughs that used to be impossible.

What You'll Do
Develop process flow diagrams, piping and instrumentation diagrams, user requirement specifications, functional requirement specifications, and detailed design specifications for new processes and equipment.
Create and implement new processes, procedures and equipment upgrades to increase production efficiency.
Coordinate pilot runs and validation.
Oversee design, fabrication, and factory/site acceptance testing for new equipment.
Create and carryout DOE protocols to improve our coating making process at scale.
Collaborate with equipment vendors and contract manufacturers in the selection and development of manufacturing processes.
Lead tech transfer activities at contract manufacturing sites (may require frequent travel).
Oversee equipment and process qualification and validation activities, including writing and executing IQ/OQ documents.
Serve as head of manufacturing.

Who You Are
Significant process development and tech transfer experience.
Experience developing processes for manufacturing emulsions or other complex fluids.
Exceptional hands-on experience and proven ability to design, qualify, and validate GMP process equipment and processes.
Ability to troubleshoot complex manufacturing processes and equipment Proven ability to handle a fast-paced, dynamic environment.
Organized, focused, and detail oriented.
Start-up experience, expertise in Lean Six Sigma, and working knowledge of CFR 210 and CFR 211 is desirable.
 
Education
B.S. in an Engineering program is desirable. 
We understand it takes a diverse team of highly intelligent, passionate, curious, and creative people to solve the challenges we are working on. Our dynamic team of humans have incredible perspectives to share, just as we know you do, and we take great pride in being an equal opportunity workplace.