Computer Systems Validation Engineer

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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:

o User access management

o Audit trail configuration and review

o Data protection and integrity controls

o Backup, restore, and disaster recovery processes

• Author and review validation lifecycle documentation, including:

o User Requirements Specification (URS)

o Functional Requirements Specification (FRS)

o System Configuration/Design Specifications

• Prepare, execute, and document validation protocols, including:

o IQ, OQ, PQ, and UAT

o Requirements Traceability Matrix (RTM)

o 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.

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.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran's status, or any other classification as required by applicable law.

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 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.

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 15 pounds occasionally. Generally work is performed in an office environment.

Competencies

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility