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:
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
Licenses:
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.
