Senior Process Validation Engineer - PPQ & Compliance

August Bioservices, LLC; Nashville (TN); On-site; USD 110,000 - 165,000; Full time

Job summary

August Bioservices, a Nashville-based CDMO, seeks a Process Validation Engineer III to lead PPQ and validation activities for drug product manufacturing. You will drive validation strategies, author protocols, and mentor junior staff while ensuring compliance with FDA/EMA/ICH guidelines.

The role emphasizes cross-functional collaboration with Manufacturing, QA/QC, and MSAT to maintain validated processes across the product lifecycle and prepare for regulatory inspections.

Qualifications

• Bachelor’s degree in biology, biochemistry, biotechnology, microbiology, chemical engineering, mechanical engineering, pharmaceutical engineering, or related discipline.
• Master’s or PhD preferred and may substitute for some experience.
• 7+ years in pharmaceutical/biopharmaceutical drug product manufacturing process validation within a cGMP environment.
• Experience leading complex validation projects and cross-functional teams.
• Regulatory inspections experience preferred.
• ASQ CQE or Lean Six Sigma Green/Black Belt certifications are a plus.

Responsibilities

• Author, review, and approve validation master plans, protocols, reports, and risk assessments for formulation and drug product manufacturing.
• Define CPPs and CQAs with development, tech transfer and Quality.
• Develop sampling plans and statistically justified acceptance criteria for PPQ campaigns.
• Establish and maintain CPV programs including SPC and trending.
• Apply quality risk management tools (FMEA, HACCP, risk ranking) per ICH Q9.
• Manage validation projects with planning, resources, and timelines.
• Execute field verification activities and ensure approved validation documentation.
• Review drawings, P&IDs, equipment specs, maintenance records for qualification.
• Write and revise SOPs, validation procedures, and validation docs.
• Support technology transfers, capital projects, equipment installations, and process improvements.
• Lead or support deviation investigations, change controls, CAPA activities affecting validated systems.
• Collaborate cross-functionally with Manufacturing, QA, QC, MSAT, Development, and Engineering.
• Act as Validation SME during audits and inspections.
• Identify opportunities to improve validation processes and documentation.

Skills

Statistical analysis

Quality systems knowledge

Cross-functional collaboration

Technical writing

Regulatory inspections experience

Education

Bachelor’s degree in biology/biochem/biotech/engineering

Master’s or PhD preferred

Tools

JMP

Minitab

Job description

August Bioservices, a Nashville-based CDMO, seeks a Process Validation Engineer III to lead PPQ and validation activities for drug product manufacturing. You will drive validation strategies, author protocols, and mentor junior staff while ensuring compliance with FDA/EMA/ICH guidelines.

The role emphasizes cross-functional collaboration with Manufacturing, QA/QC, and MSAT to maintain validated processes across the product lifecycle and prepare for regulatory inspections.