Senior Process Validation Engineer - PPQ & Compliance Lead

August Bioservices; Nashville (TN); On-site; USD 110,000 - 150,000; Full time

Job summary

August Bioservices in Nashville, TN seeks a Process Validation Engineer III to lead PPQ and validation lifecycle activities for drug product manufacturing. The role requires managing validation programs, coordinating cross-functional teams, and ensuring alignment with FDA/EMA/ICH guidelines.

The candidate will develop and execute validation strategies, author protocols, and support technology transfers while mentoring junior staff and contributing to continuous improvement initiatives.

Qualifications

• Minimum seven years of pharma/biopharma validation experience.
• Experience with cGMP, regulatory inspections, and audits preferred.
• Strong technical writing and project leadership skills.

Responsibilities

• Lead PPQ protocols, validations, and lifecycle management.
• Define CPPs/CQAs with cross-functional teams.
• Develop sampling plans and acceptance criteria for PPQ campaigns.
• Oversee CPV programs and CAPA activities.

Skills

Leadership

Statistical analysis

Documentation

Cross-functional

Quality systems

Education

Bachelor’s degree in biology/biochemistry/engineering

Master’s or PhD preferred

Tools

JMP

Minitab

Job description

August Bioservices in Nashville, TN seeks a Process Validation Engineer III to lead PPQ and validation lifecycle activities for drug product manufacturing. The role requires managing validation programs, coordinating cross-functional teams, and ensuring alignment with FDA/EMA/ICH guidelines.

The candidate will develop and execute validation strategies, author protocols, and support technology transfers while mentoring junior staff and contributing to continuous improvement initiatives.