Validation Specialist

Location: Bridgeton

** 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.
****** Key Responsibilities
******** 1. 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.
****** 2. 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).
****** Required Qualifications****
* ***
* 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 animal pharma and/or oral solid dosage product (tablets, liquids, and pastes) is preferred.**  +
** 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.
****** Essential Skills (Behavior)
****** The ideal candidate will demonstrate the following critical skills:**
* **** 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…