Cynet Systems
Cynet Systems

Validation Lead

Raritan, NJ, US • Posted 8 hours ago • Updated 8 hours ago
Contract Corp To Corp
Contract W2
6 Months
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Acceptance Testing
  • Acquisition
  • Biotechnology
  • Business Systems
  • Communication
  • Computerized System Validation
  • Data Migration

Summary

We are looking for Validation Lead - Hybrid for our client in Raritan, NJ.

Job Title: Validation Lead

Job Location: Raritan, NJ

Job Type: Contract

Job Overview:

Pay Range: $50.00hr - $55.00hr

Requirement/Must Have:

  • 7-10 years of relevant experience in Infrastructure Qualifications and Business Systems Validations.
  • Experience leading or advising junior and senior resources.
  • Specific experience in the pharmaceutical, biotechnology, or medical device industry.
  • Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation.
  • Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts.
  • Experience in writing and executing documentation for all aspects of validation deliverables including requirements, compliance/validation plans, test protocols, test summary reports, and SOPs/WIs.
  • Experience in reviewing system test and user acceptance test scripts, traceability matrices, and design specifications.
  • Experience in QA methodologies, including designing, reviewing, and approving test plans and procedures.
  • Strong verbal and written communication skills.
Responsibilities:
  • Independently support business separation activities for large global and regional GxP computerized systems with minimal supervision.
  • Manage end-to-end processes from inventory and assessments to remediations and final dispositions.
  • Define and implement risk-based validation activities.
  • Review and approve test plans, systems, and UAT test scripts.
Nice to Have:
  • Recent experience with acquisitions, separations, or divestitures within a similar organizational environment.
Skills:
  • Computer System Validation.
  • M&A Data Migration.
  • Infrastructure Qualification.
  • Data Platform Domain.
  • GxP Standards.
  • Risk Based Validation.
  • QA Methodologies.
  • UAT Testing.
Qualification And Education:
  • 7-10 years of relevant experience in Infrastructure Qualifications and Business Systems Validations.
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: 10516350
  • Position Id: NJ_VLDA_0819
  • Posted 8 hours ago
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