Sr. CSV Consultant- Visa Independent

Role - CSV Consultant Location - Raritan, NJ(Hybrid) Job Details: Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance s and industry standards (i.e., GAMP) Experience in writing and execut

Job Details: Ex-J&J preferred Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance s and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of

Job Title: IM Regulatory Validation Lead Location: Raritan, NJ (Hybrid) Job Details: Experienced Validation lead to support end to end validation ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack 8+ years experience in Computer System Validation or Quality management or Business Analysis in GxP application area Act as single point of accountability for validation deliverables, Responsible to Author Validation Deliverables which includes - Validation / Co

JD -Act as Technical Product Owner, BA for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.Manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.Collaborate with development, QA, and regulatory teams to ensure product features mee