SumasEdge Corporation
SumasEdge Corporation

Computer System Validation (CSV) Consultants (Only Visa Independent Candidate/W2)

Piscataway, NJ, US • Posted 1 hour ago • Updated 1 hour ago
Contract Independent
Contract W2
12 Months
No Travel Required
On-site
Depends on Experience
Fitment

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Job Details

Skills

  • LIMS
  • Computerized System Validation
  • DS
  • Data Integrity
  • Auditing
  • Biotechnology
  • CMMS
  • PQ
  • GxP
  • IQ
  • Life Sciences
  • Manufacturing
  • OQ
  • Risk Assessment
  • SAP
  • SAP MM
  • SAP PP
  • SAP QM
  • Change Control
  • DirectShow
  • Documentation
  • GAMP
  • Traceability Matrix
  • URS

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: 90859492
  • Position Id: 9066218
  • Posted 1 hour ago
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