Process Validation Engineer III

August Bioservices • Nashville, TN

1d

About The Position

The Process Validation Engineer III independently leads process performance qualification (PPQ) and 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. It develops validation strategies, authors and executes PPQ protocols, oversees continued process verification, and serves as a technical subject matter expert for technology transfers, process improvements, and regulatory inspections.

The role leads the design, execution, and maintenance of process validation programs for drug product manufacturing, keeping processes in a validated state and compliant with cGMP, FDA, EMA, and ICH requirements throughout the product lifecycle, from technology transfer through commercial manufacturing. It also provides technical expertise and mentors junior staff.

Requirements

• Bachelor’s degree in biology, biochemistry, biotechnology, microbiology, chemical engineering, mechanical engineering, pharmaceutical engineering, or a related scientific or engineering discipline.
• At least seven years of experience in pharmaceutical or biopharmaceutical drug product manufacturing process validation within a cGMP-regulated pharmaceutical, biotechnology, or sterile manufacturing environment.
• Demonstrated experience leading complex validation projects and serving as a technical resource for cross-functional teams.
• 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, including capability analysis, control charts, DoE, and tolerance intervals.
• Experience developing Validation Master Plans, risk assessments (FMEA, SIA, FRA), discrepancy investigations, CAPAs, and technical validation reports.
• Experience with management systems such as Master Control, Blue Mountain, or equivalent.
• Excellent written, verbal, and interpersonal communication skills, including the ability to collaborate across technical and operational functions.
• Strong technical writing skills and ability to produce clear, inspection-ready documentation.
• Understanding of data integrity principles (ALCOA+).
• Ability to meet the physical requirements of the role, including desk and computer work, walking and standing in manufacturing and laboratory environments, cleanroom gowning and PPE use, occasional lifting, carrying, pushing, or pulling up to 40 pounds and frequent handling up to 30 pounds, and the visual acuity and manual dexterity needed for detailed documentation and sensitive testing instruments.

Nice To Haves

• Master’s or PhD in a relevant discipline; may substitute for some experience.
• Experience supporting regulatory inspections and customer audits.
• Certifications such as ASQ CQE or Lean Six Sigma Green Belt or Black Belt.

Responsibilities

• Author, review, and approve validation master plans, protocols, reports, and risk assessments for formulation and fill/finish drug product manufacturing.
• Define critical process parameters and critical quality attributes with Process Development, technology transfer, and Quality teams.
• Develop sampling plans and statistically justified acceptance criteria for PPQ campaigns.
• Establish and maintain continued process verification programs, including statistical process control, trending, and periodic reporting.
• Apply quality risk management tools, including FMEA, HACCP, and risk ranking, consistent with ICH Q9.
• Manage validation projects by planning schedules, coordinating resources, monitoring progress, and ensuring timely completion.
• Execute field verification activities and oversee protocol execution in compliance with approved validation documentation.
• Review engineering and process flow drawings, P&IDs, equipment specifications, maintenance records, and history files to support qualification activities and maintain validated systems.
• Author and revise SOPs, validation procedures, and technical documentation supporting validation lifecycle management.
• Participate in technology transfers, capital projects, equipment installations, and process improvements to incorporate validation requirements throughout project execution.
• Lead or support deviation investigations, change controls, risk assessments, root cause analyses, and 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 during customer audits, regulatory inspections, and cross-functional project meetings.
• Identify opportunities to improve validation processes, documentation, and execution through continuous improvement initiatives.
• Ensure validation activities comply with company QMS requirements and applicable FDA, EMA, and international regulatory guidance.
• Mentor junior staff.
• Lead process validation activities and manage lifecycle validation of manufacturing processes and computerized systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior