Piscataway, NJ (onsite - physical presence required) Reports To: Sr. Director of IT Work ... Partner with system owners, QA, and IT to maintain systems in a validated state through change ...
Piscataway, NJ (onsite - physical presence required) Reports To: Sr. Director of IT Work ... Partner with system owners, QA, and IT to maintain systems in a validated state through change ...
Piscataway, NJ (onsite - physical presence required) Reports To: Sr. Director of IT Work ... Partner with system owners, QA, and IT to maintain systems in a validated state through change ...
Piscataway, NJ (onsite - physical presence required) Reports To: Sr. Director of IT Work ... Partner with system owners, QA, and IT to maintain systems in a validated state through change ...
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This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
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This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
Senior Specialist, IT Compliance & Validation
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This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with ...
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Central to its mission is the Recursion Operating System (OS), a platform built across diverse technologies that continuously expands one of the world's largest proprietary biological, chemical and ...
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Computer System Technology information
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A Computer System Technology job involves working with computer hardware, software, networks, and systems to ensure they function efficiently. Professionals in this field may install, maintain, troubleshoot, and upgrade computer systems for businesses and organizations. They often work in IT support, network administration, cybersecurity, or systems analysis. This role requires strong technical skills, problem-solving abilities, and knowledge of industry-standard tools and technologies.
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Posted 11 days ago
Job description
Description
Position Type: Full-time Employee (FTE)
Location: Piscataway, NJ (onsite - physical presence required)
Reports To: Sr. Director of IT
Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future
Position Summary
We are seeking an experienced 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 Duties & Responsibilities
- 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
- Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
- Support audits, inspections, CAPA investigations, and deviations related to computerized systems
- Collaborating with senior validation leads and SMEs to drive consistent practices across sites
Requirements
Position Requirements and Qualifications
- Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment
- Minimum 5 years of CSV experience in a GxP-regulated environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
Experience:
- Minimum 5 years of CSV experience in a GxP-regulated environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
Specialized Knowledge and Skills:
- Familiarity with GAMP 5 principles and risk-based validation
- Exposure to Caliber LIMS
- Exposure to SAP (QM, MM, PP) in a GxP context
- Experience with BMRAM or equivalent CMMS/calibration systems
- Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams
Work Environment & Physical Demands:
- This is an on-site position
- Must be able to work extended hours or weekend hours, as may be required.
Noise:
- No extraordinary noise levels.
Standing/Lifting:
- Very unlikely, but can be able to lift at least 20 lbs.
Visual:
- No extraordinary requirements.
Stress:
- High-paced demanding environment to meet ambitious project goals.
Travel:
- Moderate domestic travel may be required.
About Kashiv BioSciences
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
201 - 500 Employees
Headquarters location
Piscataway, NJ, US
Year founded
2011