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Lab System Validation

Job

The Akanksha LLC

Rahway, NJ (In Person)

$96,720 Salary, Full-Time

Posted 6 days ago (Updated 3 days ago) • Actively hiring

Expires 7/20/2026

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Job Description

Lab System Validation The Akanksha LLC Rahway, NJ Job Details Contract $45 - $48 an hour 5 hours ago Qualifications Jira Content creation for technical audiences Requirements specification Technical documentation Laboratory instrument validation Pharmaceutical company experience Requirements analysis Technical writing within technology
SDLC Full Job Description Role:
Lab System Validation Location:
Rahway, NJ onsite
Duration:
12
Month JD:
o Experience/ exposure to Computerized System Validation (CSV), US
FDA 21 CFR
Part 11, EU Annex 11 and GAMP 5. o Experience of CSV Validation in any one of the Lab systems is must. o Should worked in pharmaceutical domain and its related knowledge is must o Good communication and technical writing skills are a must o Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments. o Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. o
CSV, GAMP 5 CPFR
Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred. o To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas o Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement. o Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc. o Exposure to Regulatory Audits and Remediation activitieso Ensure the CSV artefacts are in line and meets regulatory requirementso Preferred Experience in Agile Developmento Knowledge on working in Jira / Service Nowo Adaptation to AI is preferred Testing (in addition to above) o Experience in testing and knowledge in any one of the QC/R D Lab systems is must. o Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must. o Knowledge on working in Jira, HP ALM or any automation testing tools.
Pay:
$45.00 - $48.00 per hour
Work Location:
In person