Validation Specialist

2 weeks ago


Bridgeton, United States Virbac Full time
Experiencing together a unique human adventure

Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.

Validation Specialist

Virbac Animal Health is seeking a Validation Specialist to join our MSAT team. The Validation Specialist prepares, executes, and summarizes validation/qualification protocols and other related documents (risk assessments, project plans, periodic reviews, URS, FRS, IQ/OQ/PQ, SAT, FAT etc.) to support the validation/qualification program at Virbac St. Louis. The Validation Specialist also performs other activities related to compliance and providing validation support for manufacturing issues or special projects as needed.

Qualified candidates must possess a Bachelor's degree in a technical/science/mathematical field . The ideal candidate would have 3+ years of experience in GMP Field. They would also possess experience in performing primary duties in pharmaceutical health care or a related regulated industry, writing/executing protocols and reports or similar activity. Validation/qualification experience in a biotech/pharmaceutical environmental or related regulated industry preferred. Experience in the animal pharma industry and/or oral solid dosage industry are preferred.

This exciting position will work in Bridgeton, MO. It comes with an excellent benefits package including generous time off, 401k + match, life, medical, dental, and vision benefits, and more

Qualification and Validation Projects

Main activities:
  • Draft qualification/validation protocols that meet internal procedures, domestic and international regulatory requirements. Protocol subject areas may include system qualification, cleaning validation, computer system validation and process validation (PPQ). Protocols are developed to trace user, functional and design specification as applicable.
  • Additionally, create and/or revising other supporting documents, including URS, System Impact Assessments, functional and design specifications, risk assessments, periodic reviews, commissioning documents, validation project plans, and others.
  • Coordinate with maintenance and operations to develop all supporting documentation including cleaning procedures, instructions for use, maintenance work instructions and training plans.
  • Work with planning, laboratory, maintenance and operations to execute all systems and process testing and to complete the testing documentation.
  • Draft reports and draw conclusions regarding the appropriateness of the system or process for its intended use, including statistical analysis of data generated by validation studies.
  • Manage the document flow for protocols, working copies and completed reports through the entire life cycle, ensuring proper documentation on all protocol entries.
  • Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to equipment qualification projects
  • Support Change Control processes, performing assessment of system changes, and execution of revalidation and/or re-qualification activities as needed.
Expected results: Qualifications/validations are completed appropriately, and on schedule as promised in the annual or specific project plan.

Continuous improvement of the Validation department

Main activities:
  • Develop, maintain and review for continuous improvement the use of protocol templates to develop consistency for all protocols and associated validation documents.
  • Develop, maintain and review department procedures when required and for continuous improvement, keeping current with industry regulation and guidance.

Expected results: Contribute to the continuous improvement of the department with template and procedure creations/revisions.

Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension.

Joining Virbac means joining dynamic teams ambitious for success.

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