CSV Specialist

Validation Lead Raritan, NJ (Remote and Hybrid preferred) W2 Contract Must Have - Computer System Validation - Validation exp. Infrastructure and Tools - AWS/Azure etc. Key Responsibilities: Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. AWS, Azure, JIRA, ServiceNow etc. Any recent experience with divestiture/separation in J&J a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications), Ability to manage mu

Job Title - Validation Lead Location - Raritan, NJ(Hybrid) Mandatory skills - Validation exp. Infrastructure and Tools AWS/Azure etc. Key Responsibilities: Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. AWS, Azure, JIRA, ServiceNow etc.Any recent experience with divestiture/separation in J&J a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications),Ability to manage multiple dispositions for multiple J&J Man

CSV Lead Consultant Princeton, NJ (Hybrid, 3 days in Office) Long Term Contract Mandatory Skills- Computer System Validation (CSV), GxP Systems & Compliance, Manufacturing Domain Knowledge, Labeling Systems Knowledge, Validation Testing (IQ/OQ/PQ) , Validation Documentation , FDA 21 CFR Part 11 / GAMP5 , Risk Assessment & Change Control , Stakeholder Management , Audit & Inspection Support Role Summary We are seeking an experienced Computer System Validation (CSV) Professional with strong exper

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument s