Senior Process Validation Engineer – PPQ & CPV Lead

August Bioservices LLC; Nashville (TN); On-site; USD 110,000 - 160,000; Full time

Job summary

August Bioservices, headquartered in Nashville, is seeking a Process Validation Engineer III to lead PPQ activities and maintain validated processes across the product lifecycle. You will develop strategies, author validation documentation, and mentor junior staff while ensuring compliance with FDA, EMA, and ICH guidelines.

The role requires expertise in validation master plans, CPPs, and CQAs, with strong statistical and technical writing skills.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline required.
• Master’s or PhD preferred and may substitute for experience.
• Minimum of seven years in pharmaceutical/biopharmaceutical process validation within a cGMP-regulated environment.
• Experience leading complex validation projects and cross-functional teams.
• Experience supporting regulatory inspections and customer audits preferred.

Responsibilities

• Lead PPQ/validation activities for drug product manufacturing.
• Define CPPs and CQAs with cross-functional teams across departments.
• Develop sampling plans and statistically justified acceptance criteria for PPQ campaigns.
• Establish and maintain CPV programs with statistical process control, trending, and reporting.
• Lead deviation investigations, change controls, risk assessments, root cause analyses, and CAPA for validated systems.
• Support technology transfers, capital projects, equipment installations, and process improvements.

Skills

Process validation knowledge

Statistical analysis

Technical writing

Cross-functional collaboration

SOP development

CAPA investigations

ALCOA+ data integrity

Education

Bachelor's degree in related field

Master's or PhD preferred

Tools

JMP

Minitab

DoE

FMEA

Job description

August Bioservices, headquartered in Nashville, is seeking a Process Validation Engineer III to lead PPQ activities and maintain validated processes across the product lifecycle. You will develop strategies, author validation documentation, and mentor junior staff while ensuring compliance with FDA, EMA, and ICH guidelines.

The role requires expertise in validation master plans, CPPs, and CQAs, with strong statistical and technical writing skills.