Process Validation Engineer III

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.

Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

The Process Validation Engineer III independently leads process performance qualification (PPQ)/process validation activities for pharmaceutical manufacturing. The role manages lifecycle validation of manufacturing processes and computerized systems to ensure compliance with cGMP requirements and regulatory expectations. Responsibilities include developing validation strategies, authoring and executing PPQ protocols, overseeing continued process verification, and serving as a technical subject matter expert for technology transfers, process improvements, and regulatory inspections.

The Process Validation Engineer leads the design, execution, and maintenance of process validation programs for drug product manufacturing. The role keeps processes in a validated state, compliant with cGMP, FDA, EMA, and ICH requirements, across the product lifecycle from technology transfer through commercial manufacturing. The engineer also serves as a technical subject matter expert and mentor’s junior staff.

• Author, review, and approve validation master plans (VMPs), protocols, reports, and risk assessments for formulation, fill/finish drug product manufacturing.
• Define critical process parameters (CPPs) and critical quality attributes (CQAs) in partnership with Process Development, tech transfer and Quality.
• Develop sampling plans and statistically justified acceptance criteria for PPQ campaigns.
• Establish and maintain CPV programs, including statistical process control, trending, and periodic reporting.
• Apply quality risk management tools (FMEA, HACCP, risk ranking) consistent with ICH Q9.
• Manage validation projects, including planning schedules, coordinating resources, monitoring progress, and ensuring timely completion.
• Execute field verification activities and oversee protocol execution while ensuring compliance with approved validation documentation.
• Review engineering/process flow drawings, P&IDs, equipment specifications, maintenance records, and history files to support qualification activities and maintain validated systems.
• Author and revise Standard Operating Procedures (SOPs), validation procedures, and technical documentation supporting validation lifecycle management.
• Participate in technology transfers, capital projects, equipment installations, and process improvements to ensure validation requirements are incorporated throughout project execution.
• Lead or support deviation investigations, change controls, risk assessments, root cause analyses, and Corrective and Preventive Action (CAPA) activities affecting validated systems.
• Work cross-functionally with Manufacturing, Quality Assurance, Quality Control, MSAT, Process Development, and Engineering.
• Serve as the Validation subject matter expert (SME) during customer audits, regulatory inspections, and…