Senior Process Validation Engineer – PPQ & Validation Leadership

August-Bioservices; Nashville (TN); On-site; USD 110,000 - 140,000; Full time

Job summary

August Bioservices in Nashville seeks a Process Validation Engineer III to lead PPQ and validation activities for drug product manufacturing. You will ensure cGMP compliance, develop strategies, author protocols, and mentor staff across the lifecycle from tech transfer to commercial manufacturing.

The role requires strong knowledge of FDA guidance, ICH Q8–Q11, and statistics, with cross-functional collaboration across Manufacturing, Quality, MSAT, and Process Development.

Qualifications

• Requires B.S. in a scientific/engineering discipline with advanced degrees preferred.
• 7+ years in pharmaceutical/biopharmaceutical process validation in a cGMP environment.
• Experience leading complex validation projects and supporting regulatory inspections.

Responsibilities

• Lead PPQ and process validation activities for drug product manufacturing.
• Develop validation strategies, protocols, and reports; manage CPV programs.
• Author SOPs and validation documentation; mentor junior staff.
• Support technology transfers, capital projects, and process improvements to ensure validation requirements are incorporated.
• Serve as SME during customer audits and regulatory inspections; drive continuous improvement.

Skills

FDA Process Validation Guidance

ICH Q8–Q11

Statistical analysis

Quality systems

Cross-functional leadership

Education

Bachelor's degree in biology/engineering

Master’s or PhD preferred

Tools

JMP

Minitab

Blue Mountain Master Control

Job description

August Bioservices in Nashville seeks a Process Validation Engineer III to lead PPQ and validation activities for drug product manufacturing. You will ensure cGMP compliance, develop strategies, author protocols, and mentor staff across the lifecycle from tech transfer to commercial manufacturing.

The role requires strong knowledge of FDA guidance, ICH Q8–Q11, and statistics, with cross-functional collaboration across Manufacturing, Quality, MSAT, and Process Development.