Job Description

RESPONSIBILITIES:
•Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.
•Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.
•Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
•Author, review and/or approve applicable CSV documentation.
•Perform or oversee test script execution efforts, including defect management.
•Ensure validation test strategies align with internal procedures and requirements for intended use.
•Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
•Experience in following CSV methodology for system evaluations, changes, and implementations.
•Ability to work independently.

Requirements:

• Education: Master's Degree with 2+ years of direct experience in Validation in pharmaceutical, biotechnology.
• Related industry, preferably in FDA-regulated environments.
• Bachelor's Degree with 4+ years of direct experience in Validation.
• Pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.

• Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
• Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
• 3-5+ years' experience in performing periodic review of computerized systems.
• Experience with Val genesis/Veeva Vault CR/PR/CAPA systems.
• Strong critical thinking and problem-solving skills.
• Strong interpersonal skills to work with teams in different functions and organizations GXP Equipment Validation.

Job Tags

Similar Jobs