Computer Systems Validation Engineer

Job Description

• 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.

Qualification and Experience

• MS/BA Degree in Computer Science, IT, Engineering, Science, or Business
• 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.

Physical Requirements

• The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing.
• In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply.
• This position may require lifting up to 35 pounds occasionally.
• Generally work is performed in a combination of a corporate and manufacturing environment.

Pay

The anticipated salary range for this position in New Jersey is $90,000 - $110,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility