QA Validation Engineer

About the role

Location: Lenexa, KS. The QA Validation Engineer leads, designs, performs, and reports validation activities on processes, equipment, and systems used in the manufacture of regulated veterinary vaccines for domestic and international markets.

Responsibilities

• Prepare and execute protocols including Cycle Development, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Engineering Studies (ES), Factory Acceptance Test (FAT), and Site Acceptance Test (SAT).
• Review protocol drafts and resolve conflicts or concerns to achieve management pre‑approval.
• Coordinate qualification execution and all aspects of validation projects with Operations, Engineering, Quality Control, and Quality Assurance.
• Perform or supervise protocol execution and maintain documentation in compliance with current Good Documentation Practices (GDP).
• Review, analyze, and compile protocol data and write reports for management review and approval.
• Perform and document risk assessments to determine validation strategy and approach.
• Execute re‑qualification (RQ) studies and periodic reviews to ensure equipment, systems, and processes remain in a validated state.
• Support and participate in change control processes for qualified and validated equipment, including refrigerators, freezers, incubators, autoclaves, lyophilizers, bioreactors, fermenters, ovens, ampule filling machines, and related systems; maintain full understanding of applicable change control procedures.
• Provide input to, review, and approve User Requirements Specifications (URS).
• Write, review, and edit standard operating procedures (SOPs) to align with validation requirements.
• Provide input to Engineering on the preparation and execution of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
• Research equipment and processes to establish parameters and testing methods that meet validation requirements.
• Support the development of Validation Plans and Schedules.
• Ensure processes and products comply with all local, state, and federal regulations; oversee CGMP compliance and establish systems that identify opportunities for improvement and recommend changes to improve process effectiveness and quality.
• Perform all other duties as assigned.

Requirements

• Bachelor’s degree in Engineering, Biotechnology, Biology, or Microbiology with 4+ years of validation experience in a biotech, biological, pharmaceutical, or other GMP‑regulated industry OR Master’s degree in Engineering, Biotechnology, Biology, or Microbiology with 2+ years of validation experience in a biotech, biological, pharmaceutical, or other GMP‑regulated industry.
• Ability to read, write legibly, and communicate in English.
• Visual inspection capability.
• Occasional lifting up to 25 pounds.
• Tasks frequently require prolonged mental and visual concentration.
• Travel: None.

Skills

• Ability to perform internal and study audits as a lead and participate in external audits as a member of the audit team.
• Knowledge of pharmaceutical development, regulatory requirements, and manufacturing sciences with a global perspective.
• Knowledge of quality systems tools with the ability to adapt them to organizational needs and global regulatory requirements (GLP, GCP, GMP).
• Ability to validate Excel file programming according to defined objectives.
• Proficiency in the use of data logging equipment and instruments.
• Experience performing risk assessments, investigations, CAPAs, and Aseptic Process Simulations (APS or media fills) preferred.