Principal Engineer, Fill and Finish, Technical Operations

Danaher•Fargo, ND

6d•Onsite

About The Position

Aldevron, one of Danaher’s operating companies, is a world-class CDMO that accelerates the development of groundbreaking therapies. Their mission is to be the engine of innovation for genomic medicine pioneers. The Principal Engineer, Fill/Finish is responsible for building and delivering on the Fill/Finish engineering strategy to improve and grow Drug Product manufacturing capability. This position reports to the Sr. Manager, Automation and Process Engineering and is part of the Technical Operations department. This role is an on-site position in Fargo, ND.

Requirements

Bachelors degree in engineering, life sciences or related field
10 years of engineering experience, with some years in a CDMO or drug product manufacturing facility, focused on fill/finish equipment
Knowledge of cGMPs, aseptic processing, contamination control, regulatory expectations (both USP as well as EU).
Experience with equipment such as automated and semi-automated fillers, isolators, cappers, inspection systems, and secondary packaging lines.
Experience with audits, investigations, risk assessments, and validation programs

Responsibilities

Serve as subject matter expert for aseptic fill/finish operations encompassing both Drug Substances and Drug Products from early to late phase applications.
Provide expertise during audits and inspections.
Drive implementation and improvements to specified equipment.
Develop engineering strategies for process robustness, process validation, and contamination control.
Mentor junior engineers and provide technical guidance.
Lead deviations, investigations, CAPAs, and risk assessments as a subject matter expert.
Support equipment lifecycle activities (URS, FAT/SAT, commissioning, IQ/OQ/PQ).
Help to maintain and improve current sterility assurance programs, including aseptic process simulations (APS), container closure integrity testing (CCIT), and environmental monitoring performance qualification (EMPQ).
Support PPQ strategies and validation lifecycle management for filling activities.