Quality Systems Engineer (CSV) – Validation & Compliance

Lupin Pharmaceuticals; New Jersey; On-site; USD 70,000 - 90,000; Full time

Job summary

Lupin Pharmaceuticals is seeking an experienced Quality Engineer-CSV to drive administration, validation, maintenance, and continuous improvement of computerized Quality Systems across laboratory, manufacturing, and Quality operations in New Jersey.

The role covers system administration, end-user support for Veeva Vault QMS and QualityDocs, and ensuring compliance with 21 CFR Part 11 and EU Annex 11. Salary range $70,000–$90,000 with a 7.5% bonus; final offer depends on experience.

Qualifications

• 3–8 years of experience in Quality Systems, CSV, systems administration.
• Experience supporting laboratory, manufacturing, and/or enterprise computerized systems.
• Knowledge of GAMP 5, Annex 11, CSV, data integrity, and FDA/EU requirements.
• Experience with Veeva Vault or similar electronic Quality Systems preferred.

Responsibilities

• Administer and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications.
• Support system administration activities including user/role management, security configuration, audit trails, backup/restore, reporting, and other system configurations.
• Provide end-user and operational support for Veeva Vault QMS, QualityDocs, Vault Training, and other quality systems.
• Maintain and improve electronic Quality Systems, including workflows, configurations, procedures, and system processes.
• Develop and monitor Quality System metrics/KPIs, identify trends, and present results and improvement opportunities to management.
• Identify opportunities to simplify, standardize, and improve the efficiency of Quality and computerized system processes.
• Perform CSV and data integrity activities including risk assessments, URS, configuration specifications, testing/UAT, RTM, validation reports, periodic reviews, and SOP updates.
• Support qualification (Installation, Operational, and Performance Qualification) reviews of laboratory instruments and manufacturing equipment.
• Partner with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement system enhancements.
• Ensure compliance with 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, GAMP 5, Data Integrity.

Skills

GAMP 5

Annex 11

CSV

Data integrity

FDA/EU requirements

Tools

Veeva Vault

LIMS

ELN

SAP

MES

Job description

Lupin Pharmaceuticals is seeking an experienced Quality Engineer-CSV to drive administration, validation, maintenance, and continuous improvement of computerized Quality Systems across laboratory, manufacturing, and Quality operations in New Jersey.

The role covers system administration, end-user support for Veeva Vault QMS and QualityDocs, and ensuring compliance with 21 CFR Part 11 and EU Annex 11. Salary range $70,000–$90,000 with a 7.5% bonus; final offer depends on experience.