The CSV Consultant will be responsible for supporting Computer System Validation (CSV) activities across GMP laboratory and manufacturing environments at Somerset, New Jersey site reporting to CSV Manager. The role includes execution of validation lifecycle deliverables, implementation of data integrity (DI) and IT controls, and ensuring compliance with applicable regulatory requirements including 21 CFR Part 11 and GAMP 5 guidelines. The candidate is expected to independently manage multiple validation projects and collaborate with cross-functional teams and external vendors.

Key Responsibilities

• Ensure compliance with regulatory requirements including 21 CFR Part 11, Electronic Records and Electronic Signatures, and applicable predicate rules, aligned with CSA (Computer Software Assurance) and GAMP 5 principles.
• Support validation activities in GMP laboratory and manufacturing systems, including system implementation, upgrades, and remediation.
• Work on networked and standalone systems, including PLC/firmware-based computerized systems.
• Implement and assess IT and Data Integrity controls, including:
• User access management
• Audit trail configuration and review
• Data protection and integrity controls
• Backup, restore, and disaster recovery processes
• Author and review validation lifecycle documentation, including:
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• System Configuration/Design Specifications
• Prepare, execute, and document validation protocols, including:
• IQ, OQ, PQ, and UAT
• Requirements Traceability Matrix (RTM)
• Discrepancy reports and validation summary reports
• Collaborate with business stakeholders to gather requirements and ensure timely reviews and approvals of validation documentation.
• Support and manage activities within quality systems such as TrackWise Digital, Veeva, and prior experience in using electronic systems is mandatory.
• Execute system upgrades (including SaaS systems), PLC/SCADA/Firmware-based systems and perform validation activities to maintain systems in a validated state.
• Act as a System Administrator for GxP systems, including configuration and troubleshooting whenever required.
• Coordinate with cross-functional teams (QA, IT, Engineering, QC, Production) and external vendors to ensure successful project execution.
• Deliver multiple projects independently within defined timelines, ensuring compliance with internal SOPs and GMP standards.
• Conduct CSV remediations, gap assessments, risk assessments, and periodic reviews.

Required Qualifications

• Bachelor’s degree in engineering, Computer Science, or a related technical discipline.
• Strong knowledge of CSV lifecycle, GAMP 5, and 21 CFR Part 11 compliance requirements.
• Demonstrated experience in GMP-regulated environments (pharmaceutical or biotech).
• Hands-on experience with validation documentation and protocol execution (IQ/OQ/PQ/UAT).
• Strong understanding of data integrity principles and IT controls in GxP systems.
• Experience with enterprise and laboratory systems, including networked and standalone systems.
• Familiarity with QMS/DMS platforms such as TrackWise Digital, Veeva Vault, or MasterControl.
• Experience supporting system upgrades and SaaS validation activities.
• Strong communication and stakeholder engagement skills.
• Prior experience as a System Administrator in GxP-regulated systems is preferred.

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