Senior Quality CSV Engineer

Amneal • Full-time • Piscataway, New Jersey, United States • 20h ago

Description:

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.

Essential Functions:

Computer System Validation Activities• Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems• Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM• Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review

Compliance and Data Integrity• Execute risk assessments and data integrity assessments aligned with ALCOA+ principles• Support audits, inspections, CAPA investigations, and deviations related to computerized systems

Stakeholder Collaboration• Collaborating with senior validation leads and SMEs to drive consistent practices across sites

Additional Responsibilities:

Qualifications

Education:

Bachelors Degree (BA/BS) Life Sciences, Engineering, or IT, or equivalent laboratory experience in a life sciences environment - Required

Experience:

8 years or more in CSV experience in a GxP-regulated environment
8 years or more in Experience authoring and executing IQ/OQ/PQ protocols, and experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
in Experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams

Specialized Knowledge:

Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
Familiarity with GAMP 5 principles and risk-based validation
Exposure to Caliber LIMS, and SAP (QM, MM, PP) in a GxP context
Experience with BMRAM or equivalent CMMS/calibration systems

The base salary for this position ranges from $115,000 to $130,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.