Overview

The principal process engineer will be primarily responsible for the analysis and validation of the hollow fiber process at the Repligen site in Marlborough, MA. This includes statistically driven studies to determine critical parameters to control the process within a defined window.

Responsibilities

• SME on all aspects of hollow fiber manufacturing, testing and documentation.
• Design and run Design of Experiment studies to characterize the process to determine processing window to ensure high process yield.
• Lead validation and continuous process improvement projects to drive stabilization of the process.
• Work closely with the membrane manufacturing, engineering, and quality control teams, dedicating time to hands-on work in the operational areas.
• Creative out of the box thinking to resolve difficult project or technical problems/obstacles.
• Sound approach to problem solving aligned to business and quality requirements. Detail oriented.
• Provide mentorship, team guidance, and can execute projects with little to no direction and work with significant autonomy.
• Ability to research and implement next generation technology.
• Ability to explain difficult/technical issues to less technical staff in a manner that is clear and concise.
• Work with the EHS (Environmental Health & Safety) team to foster a safe work environment.
• Provide training in support of team goals and objectives.
• Lead by example and adhere to safety protocols, safe work practices, and wearing appropriate PPE (Personal Protective Equipment).

Qualifications

• BS or (MS preferred) in Chemical engineering, Polymer Chemistry, Material Science or relevant discipline and 10+ years of experience in Life Science or equivalent regulated environment
• 5+ years of experience in membrane development or membrane manufacturing.
• Hands-on experience desired in the hollow fiber spinning process, coupled with comprehensive expertise in the critical process parameters that govern hollow fiber membrane spinning process.
• Excellent technical experience characterizing difficult processes (ideally fiber/membrane manufacturing) and validation.
• Experience in method development and operation of various analytical instruments (e.g. Spectroscopy, HPLC, Karl-Fisher titrator), and membrane characterization tools (e.g. SEM, porometer).
• Strong written and verbal communication skills with ability to delegate tasks.
• Proficiency with standard business software is required (Office 365, Teams, etc.) along with statistical software (i.e. Minitab, JMP).