JMD Technologies Inc.

About the job
Title:
Computer Systems Validation (CSV) Specialist – Oracle ERP
Location: Framingham, MA — Onsite
Employment Type: Contract
Duration: Through end of year, with strong potential for extension
Status: Accepting Candidates
About the Role
We are seeking a hands-on Computer Systems Validation (CSV) Specialist to support validation and testing activities for regulated systems within a life sciences environment. The ideal candidate will have 4–5+ years of practical CSV experience, with strong hands-on validation execution and testing capabilities.
Experience validating Oracle ERP / Oracle Fusion Cloud applications is required. Hands-on validation experience with Master Control, Veeva, or Blue Mountain RAM is highly preferred.
Key Responsibilities
<ul>
<li>Execute Computer Systems Validation (CSV) activities within a regulated/GxP environment.</li>
<li>Develop, review, and execute validation protocols, test scripts, and test cases.</li>
<li>Perform hands-on test execution, document test results, and identify and manage validation discrepancies.</li>
<li>Prepare and maintain traceability matrices and validation documentation.</li>
<li>Support validation activities for Oracle Fusion Cloud / Oracle ERP implementations, upgrades, enhancements, and system changes.</li>
<li>Perform validation testing in accordance with approved procedures and applicable requirements.</li>
<li>Collaborate with IT, Quality, Business, and cross-functional teams throughout the validation lifecycle.</li>
<li>Support compliance with GxP, CSV, and applicable computerized system requirements.</li>
<li>Independently execute assigned validation activities while maintaining accurate and complete documentation.</li>
</ul>
Qualifications
<ul>
<li>4–5+ years of hands-on Computer Systems Validation (CSV) experience in pharmaceutical, biotechnology, or other regulated life sciences environments.</li>
<li>Oracle ERP / Oracle Fusion Cloud validation experience is required.</li>
<li>Strong hands-on experience with validation execution and testing.</li>
<li>Experience developing, reviewing, and executing validation protocols, test scripts, and test cases.</li>
<li>Experience documenting test results, identifying discrepancies, and supporting resolution of validation issues.</li>
<li>Hands-on validation experience with MasterControl, Veeva, or Blue Mountain RAM is highly preferred, with MasterControl and Veeva especially desirable.</li>
<li>Working knowledge of GxP, CSV principles, and regulated system documentation.</li>
<li>Strong documentation, communication, and organizational skills.</li>
<li>Ability to work onsite in Framingham, MA and effectively collaborate with cross-functional teams.</li>
<li>Ability to learn and support additional validation activities as needed.</li>
</ul>
Compensation (MA Pay Transparency)
- 
W-2:
$65–$70/hr
- 
C2C:
$75–$78/hr
Final rate will be based on skills, experience, and interview results.

Computer Systems Validation Specialist – Oracle ERP

Computer Systems Validation Specialist – Oracle ERP

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