Computer Systems Validation Engineer

Lupin•Franklin Township, NJ

2d•$90,000 - $110,000•Onsite

About The Position

This is an exciting opportunity for a quality-driven leader passionate about advancing patient-centric drug-device combination products and ensuring the highest standards of compliance and operational excellence. The role involves ensuring compliance with regulatory requirements, supporting validation activities in GMP laboratory and manufacturing systems, and working with various types of computer systems. The position requires collaboration with business stakeholders, cross-functional teams, and external vendors to ensure successful project execution and delivery of multiple projects independently within defined timelines.

Requirements

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.

Nice To Haves

Prior experience as a System Administrator in GxP-regulated systems is preferred.

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, and backup, restore, and disaster recovery processes.
Author and review validation lifecycle documentation, including User Requirements Specification (URS), Functional Requirements Specification (FRS), and System Configuration/Design Specifications.
Prepare, execute, and document validation protocols, including IQ, OQ, PQ, and UAT, Requirements Traceability Matrix (RTM), and 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.