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Sr. CSV/CSA/Validation Engineer

Raritan, NJ, US • Posted 2 days ago • Updated 4 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

SaaS
PaaS
Cloud Computing
Computerized System Validation
Acquisition
Inventory
Business Systems
Pharmaceutics
Biotechnology
Medical Devices
GxP
Writing
Documentation
Regulatory Compliance
WIS
System Testing
Traceability Matrix
Specification Gathering
Test Methods
Test Plans
Acceptance Testing
Scripting
Supervision
Management

Summary

Roles & Responsibilities:

Need someone strong with GXP applications, saas/paas, infrastructure, quality, cloud concepts, cloud applications, etc.
In addition to validation and regulation experience, the resource should have the following experience:
Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison.
Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
bility to manage end-end from Inventory, assessments, remediations to final dispositions;
Infrastructure Qualifications & Business Systems Validations 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:

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.

Skills.

bility to work as a team player, lead a team or accomplish tasks without supervision.
bility to work with remote teams and support several changes/projects simultaneously.
bility to provide Validation guidance, timely reviews, and escalations to 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: 91116760
Position Id: 45a14325d7d2fc197b51bfbd9a2d5c51
Posted 2 days ago

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Hybrid in Raritan, New Jersey

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3d ago

Hi ,Greetings ! We do have opening for our client, Role : Validation AnalystLocation : Raritan, NJ / New Brunswick, NJ Duration : Long-term Contract Job Description : Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. aws, azure, JIRA, ServiceNow etc. Any experience with divestiture/separation a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications), Must be able to work out of Raritan or New Brunswick Office

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