Validation Specialist

Virbac • Bridgeton, MO

2d

About The Position

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 St. Louis is seeking a highly motivated Validation Specialist I or II to join our MSAT Validation team. The specialist will be responsible for preparing, executing, and summarizing validation/qualification protocols and other related documentation (risk assessments, project plans, URS, FRS, IQ/OQ/PQ, SAT, FAT, etc.). This role is crucial to maintaining a robust validation/qualification program, ensuring compliance, and providing validation support for manufacturing issues and special projects as needed.

Requirements

• Education: At least a Bachelor’s degree in a technical, science, or mathematical field.
• Experience: Level I: Minimum of 3+ years of experience in the GMP/Validation field.
• Level II: Minimum of 6+ years of experience in the GMP/Validation field.
• Knowledge: Previous experience in a regulated, pharmaceutical industry, preferably in a validation role.
• Experience with and understanding of applicable industry regulations (e.g., FDA, EU) and industry guidances (e.g., ISPE, GAMP).
• Knowledge and/or experience with pharmaceutical equipment and systems is preferred, specifically in commissioning, qualification and validation; cleaning validation knowledge is valued.
• Proficient at writing technical documents, including validation protocols and reports.
• Proficient in MS Office and Google applications.
• Language: Must be proficient in English.
• Analyze problems and situations: Systematically gathers and evaluates relevant data, identifies root causes, and develops logical, fact-based solutions. Foresees potential challenges and proactively implements mitigation strategies.
• Show drive and results orientation: Demonstrates enthusiasm for achieving results, consistently reaching outcomes on time, on budget, and without errors. Takes responsibility for the quality of work.
• Adapt to change: Remains flexible in handling multiple projects simultaneously and shifting priorities as needed.
• Demonstrate team-work and developing cross-functional cooperation: Listens to others, shares best practices, and seeks input from colleagues to form decisions. Values diversity of opinion and supports team decisions.
• Communicate effectively: Responds to internal and external customer requests in a timely and decisive manner. Invests time to understand customer needs and proactively shares information.
• Demonstrate a capacity for learning and self-development: Is open to and actively asks for feedback, taking corrective action and striving to find new ways to learn and grow.

Nice To Haves

• Experience with animal pharma and/or oral solid dosage product (tablets, liquids, and pastes) is preferred.

Responsibilities

• Qualification and Validation Projects Draft, execute, and summarize qualification/validation protocols (system qualification, cleaning validation, computer system validation, process validation) that meet internal procedures and domestic/international regulatory requirements.
• Create and revise supporting documents including URS, System Impact Assessments, functional and design specifications, risk assessments, and periodic reviews.
• Work collaboratively with Planning, Laboratory, Maintenance, and Operations to execute testing and complete documentation.
• Draft final reports, drawing conclusions and performing statistical analysis of data to confirm the appropriateness of a system or process.
• Manage the documentation lifecycle and ensure proper Good Documentation Practices (GDP) are followed.
• Support Change Control processes, performing assessments and executing revalidation/re-qualification activities.
• Continuous Improvement Develop, maintain, and continuously review protocol templates to ensure consistency across all validation documents.
• Develop, maintain, and review department procedures, keeping current with industry regulation and guidance (e.g., FDA, EU, ISPE, GAMP).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level