Resourcesys
Resourcesys

Computer System Validation (CSV) Consultants

Piscataway, NJ, US • Posted 12 hours ago • Updated 12 hours ago
Contract W2
Contract Independent
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Change Control
  • Manufacturing
  • GxP
  • risk analysis
  • System Testing
  • Calibration
  • functional design
  • Biotechnology
  • SAP (Applications)
  • Enterprise Software Applications
  • Validation Protocols
  • Laboratory Information Management Systems
  • Carrying out Assessments
  • Computerized Maintenance Management Systems
  • Conduct of Business Sourcebook
  • Content Creation
  • Design Specifications
  • FDA Regulations
  • Iq/oq/pq
  • Manufacturing Laboratory
  • Traceability Matrix
  • User Requirements Documents
  • Auditing Skills
  • Biology
  • Corrective and Preventive Action
  • Health Sciences
  • Laboratory Techniques
  • SAP Quality Management
  • System Lifecycle

Summary


Job Title:- Computer System Validation (CSV) Consultants
Location:- Piscataway, NJ/Chicago, IL (Onsite)
Duration:- Contract to hire
Job Description

Responsibilities

  • Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
  • Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications.
  • Validate systems including LIMS, SAP, CMMS/calibration platforms, and other GxP-regulated applications.
  • Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews.
  • Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles.
  • Support audits, inspections, CAPAs, deviations, and remediation activitiesrelated to computerized systems.
  • Apply GAMP 5 and risk-based validation principles throughout the system lifecycle.
  • Support validation activities involvingCaliber LIMS, SAP QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable.

Required Qualifications

  • 5+ years of Computer System Validation experience within a GxP-regulated environment.
  • Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments REQUIRED.
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols.
  • Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation.
  • Experience validating at least two of the following:
    • Laboratory instruments
    • Manufacturing/engineering equipment
    • LIMS
    • SAP
    • CMMS/calibration systems
  • Experience working cross-functionally withQuality, IT, Laboratory, Manufacturing, and technical SMEs.
  • Bachelor's degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience.
  • Ability and willingness to work onsite 5 days per week.
  • Candidates must be interested and eligible for a contract-to-hire opportunity.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10170376
  • Position Id: 2026-1230
  • Posted 12 hours ago
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