Process Validation Engineer III

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

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.

ESSENTIAL DUTIES & RESPONSIBILITIES

• 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 cross-functional project meetings.
• Identify opportunities to improve validation processes, documentation, and execution through continuous improvement initiatives.
• Ensure all validation activities comply with company Quality Management System (QMS) requirements and applicable FDA, EMA, and international regulatory guidance.

QUALIFICATIONS

• Bachelor’s degree in biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related scientific or engineering discipline required.
• A Master’s or PhD is preferred and may substitute for some experience.
• Minimum of seven (7) years of experience in pharmaceutical/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.
• Experience supporting regulatory inspections and customer audits preferred.
• Certifications such as ASQ CQE or Lean Six Sigma Green/Black Belt are a plus.

KNOWLEDGE, SKILLS, & ABILITIES

• Advanced knowledge of the 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.
• 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+).

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods sitting at a desk and working on a computer.
• Frequently stand and walk throughout the manufacturing and laboratory environments for extended periods.
• Adhere to strict cleanroom gowning procedures and PPE usage while performing validation fieldwork.
• Ability to lift, carry, push, or pull up to 40 lbs occasionally and up to 30 lbs frequently. Two-person team lift or use of a mechanical assist device is required for loads exceeding 50 lbs.
• Possession of the necessary close visual acuity and manual dexterity for detailed documentation and operating sensitive testing instruments.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.