QA Engineer (CSV) for Quality Systems & Compliance

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

Job summary

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

Responsibilities include system administration, user management, support for Veeva Vault QMS, and data integrity activities. Must have 3–8 years in Quality Systems/CSV with knowledge of GAMP 5 and Annex 11; salary ranges from $70,000 to $90,000 plus a 7.5% discretionary bonus.

Qualifications

• Experience with GMP/compliance in CSV and electronic Quality Systems.
• Experience supporting laboratory, manufacturing, and enterprise computerized systems.
• Strong knowledge of regulatory requirements (FDA/EU) and data integrity.
• Hands-on with Veeva Vault or similar QSaaS systems preferred.
• 3-8 years of experience in Quality Systems, CSV, systems administration.

Responsibilities

• Administer and support PLCs, SCADA, Windows-based applications and QA systems.
• Support system administration activities including user/role management, security configuration, audit trails, and backups.
• Provide end-user support for Veeva Vault QMS, QualityDocs, Vault Training and other quality systems.
• Maintain and improve electronic Quality Systems, including workflows and procedures.
• Develop and monitor Quality System metrics/KPIs and present opportunities for improvement.

Skills

GAMP 5

Annex 11

CSV

Data integrity

FDA/EU requirements

Veeva Vault familiarity

Tools

Veeva Vault

LIMS

ELN

SAP

MES

Job description

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

Responsibilities include system administration, user management, support for Veeva Vault QMS, and data integrity activities. Must have 3–8 years in Quality Systems/CSV with knowledge of GAMP 5 and Annex 11; salary ranges from $70,000 to $90,000 plus a 7.5% discretionary bonus.