Senior Process Validation Engineer (Remote)

Aldevron; Sunnyvale (CA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work arrangements

Medical/dental/vision insurance

401(k) retirement plan

Paid time off

Job summary

Aldevron, a Danaher company, seeks a Senior Engineer, Process Validation to lead validation programs enabling commercialization of vital medicines. This full‑time, remote role reports to the Process Validation Manager within Technical Operations and supports projects spanning materials, drug substance and drug product.

You will apply risk‑based methods, use statistical tools, and act as SME to internal teams and external clients.

Qualifications

• Bachelor's or master's in engineering with 5+ years in process validation.
• Experience leading validation for biologics/small and large molecules.
• Knowledge of global regulatory and cGMP requirements.
• Proficiency in technical writing and deviation investigations.

Responsibilities

• Design, execute, and summarize validation deliverables across stages.
• Lead sterile fill-finish validation strategies and qualification programs.
• Apply risk-based approaches using pFMEA and DOE interpretation.
• Act as technical SME for process validation with clients and audits.
• Mentor junior validation associates in cGMP and Quality by Design.

Skills

Process validation

cGMP knowledge

Statistical analysis

Technical writing

Client-facing

Risk assessment

Education

Bachelor or Master in engineering

Tools

DOE

pFMEA

Control charts

Root cause analysis

Job description

Aldevron, a Danaher company, seeks a Senior Engineer, Process Validation to lead validation programs enabling commercialization of vital medicines. This full‑time, remote role reports to the Process Validation Manager within Technical Operations and supports projects spanning materials, drug substance and drug product.

You will apply risk‑based methods, use statistical tools, and act as SME to internal teams and external clients.