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August Bioservices, a privately-owned Contract Development Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee, is seeking a Process Validation Engineer III to independently lead process performance qualification (PPQ) and process validation activities for pharmaceutical manufacturing.
In this role, you will manage the lifecycle validation of manufacturing processes and computerized systems to ensure compliance with cGMP requirements and regulatory expectations. You will develop comprehensive validation strategies, author and execute PPQ protocols, oversee continued process verification (CPV) programs, and serve as a technical subject matter expert for technology transfers, process improvements, and regulatory inspections.
Key responsibilities include:
- Authoring, reviewing, and approving validation master plans (VMPs), protocols, reports, and risk assessments for formulation and fill/finish drug product manufacturing
- Defining critical process parameters (CPPs) and critical quality attributes (CQAs) in partnership with Process Development, tech transfer, and Quality teams
- Developing sampling plans and statistically justified acceptance criteria for PPQ campaigns
- Establishing and maintaining CPV programs, including statistical process control, trending, and periodic reporting
- Applying quality risk management tools (FMEA, HACCP, risk ranking) consistent with ICH Q9 guidelines
- Managing validation projects, including planning schedules, coordinating resources, monitoring progress, and ensuring timely completion
- Executing field verification activities and overseeing protocol execution while ensuring compliance with approved validation documentation
- Reviewing engineering/process flow drawings, P&IDs, equipment specifications, maintenance records, and history files
- Authoring and revising Standard Operating Procedures (SOPs), validation procedures, and technical documentation
- Participating in technology transfers, capital projects, equipment installations, and process improvements
- Leading or supporting deviation investigations, change controls, risk assessments, root cause analyses, and CAPA activities
- Working cross-functionally with Manufacturing, Quality Assurance, Quality Control, MSAT, Process Development, and Engineering teams
- Serving as the Validation subject matter expert during customer audits, regulatory inspections, and cross-functional project meetings
- Identifying opportunities to improve validation processes, documentation, and execution through continuous improvement initiatives
- Ensuring all validation activities comply with company Quality Management System (QMS) requirements and applicable FDA, EMA, and international regulatory guidance
The role requires mentoring junior staff and maintaining processes in a validated state throughout the product lifecycle from technology transfer through commercial manufacturing.
QUALIFICATIONS:
- Bachelor's degree in biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related scientific or engineering discipline (required). Master's or PhD preferred and may substitute for some experience.
- Minimum of 7 years of experience in pharmaceutical/biopharmaceutical drug product manufacturing process validation within a cGMP-regulated pharmaceutical, biotechnology, or sterile manufacturing environment (required)
- Demonstrated experience leading complex validation projects and serving as a technical resource for cross-functional teams
- Experience supporting regulatory inspections and customer audits (preferred)
- Certifications such as ASQ CQE or Lean Six Sigma Green/Black Belt (a plus)
- Advanced knowledge of FDA Process Validation Guidance, EU Annex 15, and ICH Q8, Q9, Q10, and Q11
- Proficiency in statistical analysis and tools such as JMP, Minitab, or equivalent (capability analysis, control charts, DoE, tolerance intervals)
- Experience developing Validation Master Plans, risk assessments (FMEA, SIA, FRA), discrepancy investigations, CAPAs, and technical validation reports
- Familiarity with Management Systems (e.g., Master Control, Blue Mountain, or equivalent)
- Excellent written, verbal, and interpersonal communication skills with the ability to effectively collaborate across technical and operational functions
- Strong technical writing skills, with the ability to produce clear, inspection-ready documentation
- Understanding of data integrity principles (ALCOA+)
