IT Validation Specialist (CSV) Position Available In Durham, North Carolina
Tallo's Job Summary: A biotech company in Durham, NC is seeking an IT Validation Specialist (CSV) on a long-term contract basis. Responsibilities include managing and executing CSV/CSA activities, ensuring compliance with regulatory standards, and collaborating with project teams. Qualifications include 4+ years of CSV experience, knowledge of GxP regulations, and strong attention to detail.
Job Description
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
