Senior Fill/Finish Engineering Lead

Radiometer; Fargo (ND); On-site; USD 120,000 - 160,000; Full time

Job summary

Aldevron, a Danaher operating company, is hiring a Principal Engineer, Fill/Finish to shape our engineering strategy for Drug Product manufacturing. This on-site Fargo, ND role reports to the Sr. Manager, Automation and Process Engineering within Technical Operations.

You will drive process robustness, validation, and contamination control while mentoring engineers and leading validation and CAPA activities across the fill/finish suite.

Qualifications

• Bachelor’s degree in engineering, life sciences or related field with ~10 years of engineering experience.
• Knowledge of cGMPs, aseptic processing, contamination control, regulatory expectations (USP and EU).
• Experience with automated/semi-automated fillers, isolators, cappers, inspection systems, and secondary packaging lines.
• Experience with audits, investigations, risk assessments, and validation programs.
• Willingness to travel up to 25%, primarily domestic with some international.
• Physically able to lift up to 50 lbs and work around large equipment.

Responsibilities

• Serve as SME for aseptic fill/finish operations across Drug Substances and Drug Products from early to late phase applications.
• Provide expertise during audits and inspections.
• Drive implementation and improvements to equipment.
• Develop strategies for process robustness, validation, and contamination control.
• Mentor junior engineers and provide technical guidance.
• Lead deviations, investigations, CAPAs, and risk assessments.
• Support equipment lifecycle activities (URS, FAT/SAT, commissioning, IQ/OQ/PQ).
• Help maintain sterility assurance programs including APS, CCIT, EMPQ.
• Support PPQ strategies and validation lifecycle for filling activities.

Skills

Aseptic fill/finish operations

cGMPs knowledge

Audits and investigations

Leadership mentoring

Travel readiness

Education

Bachelor's degree in engineering or life sciences

Tools

Automated fillers

Isolators

Inspection systems

Validation programs

Job description

Aldevron, a Danaher operating company, is hiring a Principal Engineer, Fill/Finish to shape our engineering strategy for Drug Product manufacturing. This on-site Fargo, ND role reports to the Sr. Manager, Automation and Process Engineering within Technical Operations.

You will drive process robustness, validation, and contamination control while mentoring engineers and leading validation and CAPA activities across the fill/finish suite.