ClifyX
Validation Expert with R&D Systems Exp
⭐ - Featured Role | Apply direct with Data Freelance Hub
This role is for a Validation Expert with R&D systems experience, offering a 12+ month contract in Fort Worth, TX (Hybrid). Requires 15+ years in Life Sciences, expertise in CSV, GxP, and knowledge of JIRA and Agile methodologies.
🌎 - Country
United States
💱 - Currency
$ USD
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💰 - Day rate
Unknown
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🗓️ - Date
January 17, 2026
🕒 - Duration
More than 6 months
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🏝️ - Location
Hybrid
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📄 - Contract
Unknown
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🔒 - Security
Unknown
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📍 - Location detailed
Fort Worth, TX
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🧠 - Skills detailed
#Data Privacy #Lean #Compliance #Jira #Strategy #Agile #R #Project Management #Data Integrity #Consulting #Security
Role description
Hello,
Greetings from Clifyx
Title: Validation Expert with R&D systems exp
Location: Fort Worth, TX (Hybrid-Onsite)
12+ Month Contract
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• Visa (GC/USC)
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• Detailed JD (Roles and Responsibilities)
We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for R&D applications, Risk management and Quality Management.
• 15+ yrs of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, Data Privacy, Data Integrity and Information Security
• Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of R&D systems considering GxP & Non GxP elements and recommend for risk-based testing approach as required.
• Work with Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvement plan to streamline practices, and revise CSV related SOPs as necessary.
• Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
• Knowledge on basic functions on R&D systems
• Knowledge of various tools/applications like JIRA, HP ALM, Qtest
• Successful track record using Lean/Agile approaches to validate assets
• Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments
Preferable IT background to understand larger impact of architecture / technical complexities on the program
Total Experience
15+years
Relevant Experience
15+years
Mandatory skills
CSV, CSA , GXP, GAMP
Desired skills
Validation Expert for R&D systems
Domain (Industry)
Pharma -CSV Life Science
Thanks & Best Regards,
Vishal Swami – Clifyx (US IT Recruiter)
Contact Number- 908-279-1295
LinkedIn: linkedin.com/in/vishal-swami-790a72179
Headquarters: South Plainfield, NJ – 07080
Hello,
Greetings from Clifyx
Title: Validation Expert with R&D systems exp
Location: Fort Worth, TX (Hybrid-Onsite)
12+ Month Contract
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•
•
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• Visa (GC/USC)
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•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
• Detailed JD (Roles and Responsibilities)
We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for R&D applications, Risk management and Quality Management.
• 15+ yrs of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, Data Privacy, Data Integrity and Information Security
• Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of R&D systems considering GxP & Non GxP elements and recommend for risk-based testing approach as required.
• Work with Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvement plan to streamline practices, and revise CSV related SOPs as necessary.
• Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
• Knowledge on basic functions on R&D systems
• Knowledge of various tools/applications like JIRA, HP ALM, Qtest
• Successful track record using Lean/Agile approaches to validate assets
• Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments
Preferable IT background to understand larger impact of architecture / technical complexities on the program
Total Experience
15+years
Relevant Experience
15+years
Mandatory skills
CSV, CSA , GXP, GAMP
Desired skills
Validation Expert for R&D systems
Domain (Industry)
Pharma -CSV Life Science
Thanks & Best Regards,
Vishal Swami – Clifyx (US IT Recruiter)
Contact Number- 908-279-1295
LinkedIn: linkedin.com/in/vishal-swami-790a72179
Headquarters: South Plainfield, NJ – 07080
