QA Validation Engineer

Job Summary and Purpose

The QA Validation Engineer in Lenexa, KS 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 and Key Duties

• 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.

Technical / Functional Competencies

• 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

Education

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

Physical Requirements

• 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 Required: None