Remote Senior Process Validation Engineer

Aldevron; New York (NY); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Bonus/incentive pay

Job summary

Aldevron is seeking a Senior Engineer, Process Validation to lead both internal and external validation initiatives that facilitate the development of new life-saving medicines. This fully remote position involves significant responsibility in process validation across several projects, requiring a strong background in engineering and substantial experience in biologics manufacturing.

The ideal candidate will have over 5 years in a relevant field, a solid grounding in regulatory standards, and the ability to mentor junior staff. Expected benefits include an annual salary between $100,000 to $130,000 and a comprehensive benefits package.

Qualifications

• 5+ years of experience in process validation for biologics and molecules.
• Knowledge of global regulatory and cGMP regulations.
• Proficiency in technical writing and root cause analysis.

Responsibilities

• Lead internal and external validation projects for new medicines.
• Mentor junior validation associates in process validation.
• Serve as a technical SME during audits and inspections.

Skills

Design and execute process validation

Statistical analysis

Risk assessment

Technical writing

Mentorship

Education

Bachelor or master degree in engineering

Job description

Aldevron is seeking a Senior Engineer, Process Validation to lead both internal and external validation initiatives that facilitate the development of new life-saving medicines. This fully remote position involves significant responsibility in process validation across several projects, requiring a strong background in engineering and substantial experience in biologics manufacturing.

The ideal candidate will have over 5 years in a relevant field, a solid grounding in regulatory standards, and the ability to mentor junior staff. Expected benefits include an annual salary between $100,000 to $130,000 and a comprehensive benefits package.