Process Validation Engineer 3

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.