A biotech company in Durham, NC is actively seeking a new IT Validation Specialist (CSV) on a long term contract basis.
*** Third Party candidates will NOT BE CONSIDERED! Only direct canddates. ***
About the Opportunity:
- Location: Hybrid in Durham, NC
- Schedule: 9-5, M-F, full time (40 hours per week)
- Setting: Manufacturing environment
Responsibilities:
- Serve as the primary on-site Computer System Validation (CSV) resource to support Durham, North Carolina site’s computerized systems and associated validation work
- Execute the GxP-Regulated computerized system lifecycle, ensuring compliance with regulatory standards, CSV procedures, and Data Integrity requirements.
- Manage and execute all CSV/CSA activities at the site, ensuring compliance with regulatory requirements and internal SOPs.
- Plan, organize, and lead the development and execution of all validation lifecycle documents including:
- Validation Plan
- Requirements Specification
- Risk Assessment
- System Impact Assessment
- Testing Documentation
- Requirements Traceability Matrix
- Validation Final Report
- Work closely with project teams, business partners, and Digital Quality to determine scope of validation activities
- Conduct periodic reviews of validated computerized systems to ensure continued compliance with regulations and SOPs
- Participate in change management activities for validated computerized systems as a subject matter expert, including providing thorough impact assessments of proposed changes to ensure no negative impact on system integrity or data compliance
- Providing support during regulatory and external audits, serving as a subject matter expert for CSV/CSA
Qualifications:
- 4+ years of experience in Computer Systems Validation/Assurance
- Detailed knowledge of GxP regulations and CSV/CSA principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity
- Familiarity with manufacturing computerized systems, including but not limited to:
- Manufacturing Execution Systems (MES) – Rockwell PharmaSuite
- Enterprise Resource Planning (ERP) - SAP
- Process Control Systems (PCS) – Emerson DeltaV
- IT Infrastructure
- Data Backup/Restore Solutions
- Asset Management Systems
- Bachelor's Degree or certifications in Information Technology
- Strong attention to detail and a commitment to accuracy and compliance
- Excellent communication and interpersonal skills, fostering collaboration and building strong relationships with internal and external stakeholders
- Project management skills with the ability to prioritize tasks, manage deadlines, and track progress effectively
Desired Skills:
- Experience in a Manufacturing facility
