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Validation Lead

Hybrid in Raritan, NJ, US • Posted 6 hours ago • Updated 6 hours ago

Contract W2

12 Months

50% Travel Required

Hybrid

Depends on Experience

Fitment

Dice Job Match Score™

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Job Details

Skills

CSV
VALIDATION
AWS

Summary

Job Title - Validation Lead

Location - Raritan, NJ(Hybrid)

Mandatory skills - Validation exp. Infrastructure and Tools AWS/Azure etc.

Key Responsibilities:

Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. AWS, Azure, JIRA, ServiceNow etc.
Any recent experience with divestiture/separation in J&J a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications),
Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
Must have proven track record of Large Acquisitions & Separations. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
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.

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: 10200946b
Position Id: 9076870
Posted 6 hours ago

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Vipin Kumar

Recruitment Manager @ Nityo Infotech Corporation

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