Senior Process Validation Engineer - Remote, Life Sciences

Danaher; Chicago (IL); Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work eligible

Bonus/incentive pay

Job summary

Aldevron, a Danaher operating company, is hiring a Senior Engineer, Process Validation. This role leads validation projects spanning starting materials to drug product, ensuring alignment with FDA guidance, EU GMP Annex 15, and lifecycle approaches.

You will collaborate across MSAT, manufacturing, QC, QA, and RA, and mentor junior staff. The position supports remote work with travel up to 15% to sites for project execution, audits, and inspections.

Qualifications

• Bachelor or master degree in engineering.
• 5+ years of experience in process validation.
• Knowledge of global regulatory requirements and cGMP.
• Proficiency in technical writing with deviation investigations and root cause analysis.

Responsibilities

• Design, execute, and summarize deliverables across all stages of process validation.
• Lead planning and lifecycle management of sterile fill-finish validation programs.
• Drive risk-based approaches using pFMEA, risk ranking and control charts; apply DOE interpretations.

Skills

Process validation

Project management

Risk assessment

Statistical analysis

Technical writing

Education

Engineering degree (Bachelor/Master)

Job description

Aldevron, a Danaher operating company, is hiring a Senior Engineer, Process Validation. This role leads validation projects spanning starting materials to drug product, ensuring alignment with FDA guidance, EU GMP Annex 15, and lifecycle approaches.

You will collaborate across MSAT, manufacturing, QC, QA, and RA, and mentor junior staff. The position supports remote work with travel up to 15% to sites for project execution, audits, and inspections.