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Validation Lead

Diverse Lynx

Role overview

Qualifications

  • 7-10 years of relevant experience in the Pharmaceutical, biotechnology, or medical device industry
  • Experience in FDA and/or Global regulated environment with knowledge of GxP standards
  • Experience in writing and executing documentation for validation deliverables
  • Strong verbal and written communication skills

Responsibilities

  • Manage end-to-end processes from inventory, assessments, remediations to final dispositions
  • Lead/advice junior and senior resources
  • Define and implement Risk based validation activities
  • Provide validation guidance, timely reviews, and escalations to management

Key facts

  • Remote from: Anywhere
  • Full time
  • Senior (5-10 years)
  • English

Hard skills

Other skills

  • Communication
  • Teamwork
  • Leadership
  • Problem Solving

About the company

Diverse Lynx logo

Diverse Lynx

IT Services & IT Consulting

We are a WBENC and NMSDC certified company helping our clients in their Diversity spending on Staffing or Contingent Workforce Services. Established in 2002 and headquartered out of Princeton-NJ, our 2000+ associates’ strength globally helps clients with talent across Technology, Healthcare, Life Sciences, Aerospace, Automotive, Energy, Pharmaceuticals, Retail, Telecom, Manufacturing and Engineering domains. Our presence in USA, Canada & India helps us support clients in IT, Non-IT, Healthcare, Hospital and Clinical hiring, across the globe.

Company details

Company typeLarge
IndustryIT Services & IT Consulting
Company size1001 - 5000

Links

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Job description

Job Title - Validation Lead

Location - Raritan, NJ (Remote)

Job Type- Contract

Skills - Computer System Validation Validating Dashboard, Data Lake, Data Platform

Job Details:

  • Candidates need to have hands-on experience in validating Data Platform, Data Lake or Dashboard and Analytics
  • Ability to manage multiple dispositions for multiple Managers with limited supervision.
  • Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources.
  • Specifically in the Pharmaceutical, biotechnology, or medical device industry.
  • Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
  • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs).
  • Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Strong verbal and written communication skills.
  • Ability to work as a team player, lead a team or accomplish tasks without supervision.
  • Ability to work with remote teams and support several changes/projects simultaneously.
  • Ability to provide Validation guidance, timely reviews, and escalations to TQ management










Disclaimer: Diverse Lynx LLC is an Equal Opportunity Employer. All applicants and employees are evaluated without discrimination, based solely on their qualifications, ability, competence and performance. This email and its attachments may contain confidential or proprietary information and is intended only for the recipient(s). If you received this message in error, please disregard it and notify the sender. If you no longer wish to receive our communications, you may unsubscribe at any time.
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