Remote Senior Process Validation Engineer

Aldevron; Indianapolis (IN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

Aldevron is seeking a Senior Engineer in Process Validation to lead projects that support the commercialization of life-saving medicines. This role involves designing and executing validation strategies in a remote work setup. The ideal candidate will have over 5 years of experience in process validation within biologics or pharmaceutical manufacturing, along with a Bachelor's or Master's degree in engineering.

Key responsibilities include mentoring junior associates, driving risk-based approaches, and ensuring compliance with cGMP regulations. The annual salary range is $100,000 to $130,000, along with incentive pay and a comprehensive benefits package.

Qualifications

• 5+ years of experience in process validation within biologics or pharmaceutical manufacturing.
• Knowledge of cGMP regulations and validation procedures.
• Proficiency in technical writing for investigations and assessments.

Responsibilities

• Lead internal and external validation projects.
• Mentor junior associates in process validation.
• Drive risk-based approaches using statistical tools.

Skills

Process validation

Statistical analysis

Technical writing

Risk assessment

Leadership

Education

Bachelor or Master degree in engineering

Job description

Aldevron is seeking a Senior Engineer in Process Validation to lead projects that support the commercialization of life-saving medicines. This role involves designing and executing validation strategies in a remote work setup. The ideal candidate will have over 5 years of experience in process validation within biologics or pharmaceutical manufacturing, along with a Bachelor's or Master's degree in engineering.

Key responsibilities include mentoring junior associates, driving risk-based approaches, and ensuring compliance with cGMP regulations. The annual salary range is $100,000 to $130,000, along with incentive pay and a comprehensive benefits package.