Senior Process Validation Engineer - Remote (Life Sciences)

Aldevron; Boston (MA); 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 is seeking a Senior Engineer, Process Validation to lead validation projects that enable the commercialization of vital medicines. This role reports to the Process Validation Manager and is part of the Technical Operations Department, Fargo, ND, with fully remote work options.

You will design, execute, and summarize validation across starting materials, drug substance, and drug product, applying risk-based approaches and DOE.

Qualifications

• Experience validating biologics/small and large molecules.
• Familiar with FDA EU GMP Annex 15 guidance.
• Ability to travel 15% to site for validations, inspections and client visits.

Responsibilities

• Lead design, execution, and summary of validation deliverables across materials and processes.
• Manage sterile fill-finish validation strategies and qualification programs.
• Apply risk-based methods and DOE to evaluate process performance.
• Act as SME during client audits, regulatory inspections, and cross-functional reviews.
• Mentor junior validation associates on cGMP and Quality by Design.

Skills

Process Validation

Statistical analysis

Risk assessment

Technical writing

cGMP knowledge

Travel readiness

Education

Bachelor or Master degree in Engineering

Tools

pFMEA

DOE

Control charts

Job description

Aldevron is seeking a Senior Engineer, Process Validation to lead validation projects that enable the commercialization of vital medicines. This role reports to the Process Validation Manager and is part of the Technical Operations Department, Fargo, ND, with fully remote work options.

You will design, execute, and summarize validation across starting materials, drug substance, and drug product, applying risk-based approaches and DOE.