Remote Senior Process Validation Engineer

Aldevron; Houston (TX); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) plan

Paid time off

Job summary

Aldevron is seeking a Senior Engineer, Process Validation, to lead and support internal and external validation projects for vital life-saving medicines. This role involves designing and executing validation strategies, ensuring compliance with FDA guidance, and mentoring junior associates.

The ideal candidate has a Bachelor's or Master's degree in engineering, 5+ years of experience in process validation, and a strong understanding of global regulatory requirements. This position offers remote work options and a competitive salary from $100,000 to $130,000.

Qualifications

• 5+ years of experience in process validation in pharmaceutical manufacturing.
• Prior experience in leading process development and validation stages.
• Knowledge of global regulatory requirements and cGMP regulations.

Responsibilities

• Design and summarize deliverables across three stages of process validation.
• Lead planning and execution of qualification programs for sterile manufacturing.
• Mentor junior validation associates in cGMP regulations.

Skills

Process validation

Statistical analysis

Quality by Design

Technical writing

Risk assessment

Education

Bachelor or master's degree in engineering

Job description

Aldevron is seeking a Senior Engineer, Process Validation, to lead and support internal and external validation projects for vital life-saving medicines. This role involves designing and executing validation strategies, ensuring compliance with FDA guidance, and mentoring junior associates.

The ideal candidate has a Bachelor's or Master's degree in engineering, 5+ years of experience in process validation, and a strong understanding of global regulatory requirements. This position offers remote work options and a competitive salary from $100,000 to $130,000.