What are the responsibilities and job description for the Validation (CSA) SME position at IT Minds LLC?
Title: Validation (CSA) SME
Duration: 5 months contract (candidates who are willing to be converted to FTE/Perm upon completion of contract will be moved to stop of the list)
Location: Hybrid onsite 3 days in Long Island City, NY (11101)
VISA: USC and GC only
Must Have
Duration: 5 months contract (candidates who are willing to be converted to FTE/Perm upon completion of contract will be moved to stop of the list)
Location: Hybrid onsite 3 days in Long Island City, NY (11101)
VISA: USC and GC only
Must Have
- Extensive experience within medical, pharmaceutical, or regulatory compliance environments
- Strong Computer Software Assurance (CSA) expertise; able to serve as the subject matter expert
- Excellent communication, leadership, and collaboration skills; positive and approachable demeanor
- Agile methodology knowledge/experience strongly preferred
- Provide subject matter expertise on validation project risk and complexity
- Ensure adherence to validation best practices and compliance standards
- Gather project information and requirements from system stakeholders
- Collaborate frequently with Business Analysts and cross-functional teams
- Maintain compliance with Good Documentation Practices (GDP)
- Support authoring and reviewing of validation reports and documentation
- Collect and integrate feedback from system stakeholders on deliverables
- Draft and execute GxP Assessments, Risk Assessments, Validation Plans, Test Plans, and Validation Summary Reports as needed
- Review, draft, and execute additional validation documentation when required
- Bachelor's degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or a related field
- 7 10 years of progressive experience in Computer System Validation (CSV) and Computer Software Assurance (CSA)
- Solid knowledge of GAMP 5 and 21 CFR Part 11 standards
- Prior experience in GxP or life sciences industries required
- Strong understanding of FDA regulations and compliance requirements
- Proven experience creating, reviewing, and resolving CAPAs
- Ability to work independently while meeting project deadlines
- Practical knowledge of Data Integrity and ALCOA principles is a plus
- Technical Competency: Able to translate business requirements into CSV documentation and supporting materials
- Time Management: Manages strict deadlines and competing priorities effectively
- Analytical Skills: Applies logical reasoning to identify, research, and communicate critical information
- Agility: Adapts to shifting priorities and timelines while maintaining high-quality deliverables
- Commitment to Quality: Demonstrates strong understanding of CSA, prioritizing customer safety, data integrity, and product quality
