Senior Process Validation Engineer — Remote, Biologics CDMO

Aldevron; Indianapolis (IN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work arrangements

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Aldevron, a Danaher company, seeks a Senior Engineer, Process Validation to lead and support internal and external validation projects that enable commercialization of vital new life-saving medicines. This role reports to the Process Validation Manager and is part of the Technical Operations Department in Fargo, ND, and will be fully remote.

Responsibilities include design, execution, and lifecycle management of sterile fill‑finish validation strategies and qualification programs; drive

Qualifications

• Bachelor or master degree in engineering.
• 5+ years of experience in process validation.
• Experience in biologics/small and large molecules manufacturing would be helpful.
• Knowledge of global regulatory requirements (cGMP).
• Proficiency in technical writing and deviation investigations.

Responsibilities

• Design, execute and summarize deliverables across stages of process validation.
• Lead sterile fill-finish validation strategies and qualification programs.
• Apply risk-based approaches and statistical tools to evaluate process performance.
• Serve as technical SME for process validation with internal teams and clients.
• Mentor junior validation associates in cGMP and Quality by Design.

Skills

Process Validation

Statistical Analysis

Risk Assessment

Client-facing

Mentoring

Education

Engineering degree (Bachelor/Master)

Tools

pFMEA

Control charts

DOE interpretation

Job description

Aldevron, a Danaher company, seeks a Senior Engineer, Process Validation to lead and support internal and external validation projects that enable commercialization of vital new life-saving medicines. This role reports to the Process Validation Manager and is part of the Technical Operations Department in Fargo, ND, and will be fully remote.

Responsibilities include design, execution, and lifecycle management of sterile fill‑finish validation strategies and qualification programs; drive