| Location | Raritan, NJ |
Responsibilities: , with a primary focus on Data Integrity, computerized systems, risk assessments, and data process flow mapping. The ideal candidate will be comfortable working directly with site teams and walking through laboratory and operational environments to assess systems, identify risks, and support remediation activities. This position will complement an existing Data Integrity lead whose primary focus is documentation, with this role providing stronger CSV, systems, and technical Data Integrity expertise . Key Responsibilities Support Data Integrity assessments and initiatives across laboratory, quality, engineering, automation, IT, and other site functions. Lead and support Data Process Flow Mapping , initially serving as a primary area of focus for the engagement. Conduct Data Integrity gap assessments, risk assessments, and compliance reviews for computerized systems and equipment. Perform onsite periodic reviews to identify data integrity risks, vulnerabilities, and opportunities for remediation. Provide guidance to SMEs and cross-functional stakeholders on Data Integrity, CSV, and cGMP compliance requirements . Support development and execution of Data Integrity remediation plans and track activities through completion. Perform and support Data Quality Reviews to identify potential data integrity concerns and ensure appropriate controls are in place. Partner with Quality, Engineering, Automation, QC, IT, and other functions to ensure Data Integrity and CSV requirements are incorporated into new systems, equipment, and processes. Provide CSV and Data Integrity guidance during system implementations, changes, and other project activities. Support audit and inspection readiness and serve as a Data Integrity SME during internal and external audits or regulatory inspections. Maintain current knowledge of applicable regulations, industry guidance, and best practices related to CSV and Data Integrity .