A leading bio-pharmaceutical company in Boston is seeking a Sr. Fill-Finish Process Engineer to enhance its manufacturing processes. The ideal candidate will have a strong background in aseptic pharmaceutical manufacturing, with responsibilities that include supporting the design and installation of a fill-finish suite, ensuring compliance with FDA regulations, and optimizing continuous improvement initiatives. Applicants should hold a degree in related engineering fields with at least seven years of experience in a GMP environment. This position may require travel and offers a dynamic work environment.
Qualifications
7+ years in GMP pharmaceutical or biotech manufacturing.
Experience in sterile or aseptic fill-finish operations.
Knowledge of regulatory compliance in manufacturing.
Responsibilities
Design and install a new commercial fill-finish suite.
Support commissioning and qualification activities.
Collaborate across teams to ensure project execution.
Skills
Aseptic operations
Technical writing
Problem-solving
Analytical skills
Communication
Education
Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering
Job description
A leading bio-pharmaceutical company in Boston is seeking a Sr. Fill-Finish Process Engineer to enhance its manufacturing processes. The ideal candidate will have a strong background in aseptic pharmaceutical manufacturing, with responsibilities that include supporting the design and installation of a fill-finish suite, ensuring compliance with FDA regulations, and optimizing continuous improvement initiatives. Applicants should hold a degree in related engineering fields with at least seven years of experience in a GMP environment. This position may require travel and offers a dynamic work environment.