QA Validation Engineer

CEVA SANTE ANIMALE; Lenexa (KS); On-site; USD 90,000 - 120,000; Full time

Job summary

Ceva Animal Health in Lenexa, KS is seeking a QA Validation Engineer to lead validation activities for vaccines in manufacturing. The role focuses on designing and performing IQ/OQ/PQ, FAT, SAT, and related studies, ensuring robust documentation and regulatory alignment.

You will collaborate with Operations, Engineering, QC and QA to maintain validated states and oversee GDP-compliant documentation while supporting continuous improvement and change control processes.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Biology, or Microbiology with 4+ years of validation experience in a GMP-regulated industry.
• Master’s degree in Engineering, Biotechnology, Biology, or Microbiology with 2+ years of validation experience in a GMP-regulated industry.
• Ability to read, write clearly, and communicate in English.

Responsibilities

• Prepare and execute validation protocols (IQ, OQ, PQ, FAT, SAT) and related studies.
• Coordinate qualification execution with Operations, Engineering, QC, and QA.
• Review and document validation data; write reports for management review and approval.
• Perform risk assessments and re-qualification studies to maintain validated state.
• Support change control for qualified equipment, including refrigerators, freezers, incubators, autoclaves, lyophilizers, bioreactors, fermenters, ovens, ampule filling machines, and related systems.
• Provide input to URS and SOPs to align with validation requirements.
• Assist Engineering on FAT and SAT preparation and execution.
• Develop Validation Plans and Schedules; ensure CGMP compliance and identify improvement opportunities.

Skills

Audit leadership

GLP/GMP knowledge

Excel validation

Data logging

Risk assessments

CAPAs

Aseptic process simulations

Education

Bachelor’s degree in Engineering, Biotechnology, Biology, or Microbiology

Master’s degree in Engineering, Biotechnology, Biology, or Microbiology

Tools

N/A

Job description

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a \"One Health\" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Your Missions

Location: Lenexa, KS

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

This job description is intended to convey information essential to understanding the scope, general nature, and level of work performed by job holders. It is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities, or working conditions, nor does it constitute an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet business needs.

• VEVRAA Federal Contractor


• Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

669B

Your Profile

Education – Bachelor’s degree in Engineering, Biotechnology, Biology, or Microbiology with 4+ years of validation work experience in biotech, biological, pharmaceutical or other GMP-regulated industry

OR

Master’s degree in Engineering, Biotechnology, Biology, Microbiology with 2+ years of validation work experience in the biotech, biological, pharmaceutical or other GMP-regulated industry required.