Saint Joseph, MO, 64501, USA
4 days ago
Computer System Validation Engineer
**Computer System Validation Engineer** Engineering Saint Joseph, MO, US Pay Rate Low: 80.00 | Pay Rate High: 85.00 + Added - 09/01/2025 Apply for Job We are seeking a Senior Computer System Validation (CSV) Engineer to play a critical role in ensuring the compliance and reliability of GMP lab systems and equipment. The ideal candidate will have extensive experience in validation processes, technical writing, and regulatory compliance. This role involves authoring validation documentation, conducting system testing, and working collaboratively with cross-functional teams to meet project goals. Located in St. Joseph, MO (Onsite) **Pay:** $145k-$165k **Key Responsibilities:** + Author validation documentation, including Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports. + Validate GMP lab systems and equipment to ensure compliance with regulatory requirements and industry standards. + Assure systems/applications meet requirements as outlined in the system specifications (URS/FRS) and in accordance with the Validation Plan. + Identify and escalate project risks and issues to the CSVC Manager as necessary. + Engage in multiple CSVC projects by analyzing data, establishing facts, and drawing valid conclusions to deliver results aligned with business needs and constraints. + Prepare detailed reports on defects and problems encountered during system testing. + Collaborate with business representatives to ensure test cases accurately reflect business rules and processes. + Fulfill a subject matter expert role for critical quality and compliance GxP end-use applications supporting Animal Health business processes. + Maintain strong judgment capabilities to clarify requirements and adapt to changing priorities. **Qualifications:** + Minimum of 5 years of CSV experience in GMP/regulated lab environments. + Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field. + Extensive technical writing experience in validation documentation. + Strong knowledge of computerized system testing and validation in the healthcare industry. + In-depth understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11). ​​​​​​​#INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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