Principal Engineer, Fill and Finish, Technical Operations

About the role

Aldevron, a Danaher operating company, delivers world-class CDMO services that accelerate the development of groundbreaking therapies. As the Principal Engineer, Fill/Finish, you will build and deliver on our Fill/Finish engineering strategy to improve and grow our Drug Product manufacturing capability. This on-site role is based in Fargo, ND, reports to the Sr. Manager, Automation and Process Engineering, and is part of the Technical Operations department.

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 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.

Requirements

• Bachelor’s 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 and 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.

Travel & Physical Requirements

• 25% travel may be required, primarily domestic and some international.
• Must be able to see, talk, hear, stand, walk, bend, lift up to 50 lbs, and work around large equipment.

Benefits

Aldevron offers a broad array of comprehensive, competitive benefit programs that add value to employees' lives, including health care programs and paid time off. For more details, visit Danaher Benefits Info.