Remote Senior Process Validation Engineer

Aldevron; Chicago (IL); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Aldevron is seeking a Senior Engineer, Process Validation who will lead and support validation projects essential for the commercialization of life-saving medicines. This position is part of the Technical Operations Department and allows for a fully remote work arrangement.

The ideal candidate will possess a bachelor or master degree in engineering and over 5 years of experience in biologics manufacturing process validation, demonstrating strong skills in statistical analysis and regulatory compliance.

Benefits include a competitive salary, bonus eligibility, and comprehensive health insurance offerings.

Qualifications

• 5+ years of experience in process validation for biologics/small and large molecules.
• Knowledge of cGMP regulations and global regulatory requirements.
• Proficiency in statistical tools and process capability evaluation.

Responsibilities

• Design and execute process validation plans for drug manufacturing.
• Lead risk-based approaches and drive statistical evaluation.
• Mentor junior associates and serve as a technical SME.

Skills

Statistical analysis

Risk assessment

Technical writing

Quality by Design principles

Education

Bachelor or master degree in engineering

Job description

Aldevron is seeking a Senior Engineer, Process Validation who will lead and support validation projects essential for the commercialization of life-saving medicines. This position is part of the Technical Operations Department and allows for a fully remote work arrangement.

The ideal candidate will possess a bachelor or master degree in engineering and over 5 years of experience in biologics manufacturing process validation, demonstrating strong skills in statistical analysis and regulatory compliance.

Benefits include a competitive salary, bonus eligibility, and comprehensive health insurance offerings.