Senior Aseptic Fill/Finish Engineering Lead – Life Sciences

Aldevron; Fargo (ND); On-site; USD 140,000 - 190,000; Full time

Job summary

Aldevron, a Danaher operating company, seeks a Principal Engineer, Fill/Finish to advance our Drug Product manufacturing capability in Fargo, ND. This on-site role reports to the Sr. Manager, Automation and Process Engineering within Technical Operations.

You will drive aseptic fill/finish strategies, partner with QA and manufacturing, and mentor junior engineers while ensuring cGMP compliance and ongoing process improvement.

Qualifications

• Bachelors degree in engineering, life sciences or related field.
• 10 years engineering experience, CDMO/drug product environment preferred.
• Knowledge of cGMPs, aseptic processing and regulatory expectations (USP/EU).
• Experience with automated/semi-automated fillers, isolators, cappers, inspect systems.
• Experience with audits, investigations, risk assessments and validation programs.

Responsibilities

• Lead aseptic fill/finish engineering strategy and improvements.
• Develop strategies for process robustness and validation lifecycle.
• Mentor junior engineers and provide technical guidance.
• Lead deviations, investigations, CAPAs, and risk assessments.
• Support PPQ strategies and equipment lifecycle activities.

Skills

Leadership & mentoring

Audits & investigations

Risk assessments

Process validation

Regulatory knowledge

Education

Bachelor's degree (engineering or life sciences)

Tools

Fill/finish equipment

Automated fillers

Isolators

Cappers

Inspection systems

Job description

Aldevron, a Danaher operating company, seeks a Principal Engineer, Fill/Finish to advance our Drug Product manufacturing capability in Fargo, ND. This on-site role reports to the Sr. Manager, Automation and Process Engineering within Technical Operations.

You will drive aseptic fill/finish strategies, partner with QA and manufacturing, and mentor junior engineers while ensuring cGMP compliance and ongoing process improvement.