Kaygen, Inc. ยท 1 day ago
Validation expert
Fort Worth, TX
Full-time
Onsite
Senior Level, Lead/Staff
15+ years expKAYGEN is an emerging leader in providing top talent for technology-based staffing services. They are looking for a Validation Expert with extensive experience in Computerized System Validation for R&D applications, risk management, and quality management in the Life Sciences industry.
AnalyticsBig DataData ManagementInformation ServicesInformation TechnologyStaffing Agency
Responsibilities
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
Qualification
Required
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, Client 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
Required Exp - 15+ Years
Mandatory Skills- CSV, CSA, GXP, GAMP
Validation Expert for R&D systems
Domain/Industry - Pharma-CSV Life Science
Preferred
Preferable IT background to understand larger impact of architecture / technical complexities on the program
Benefits
Free Healthcare Insurance
Vision and Dental Insurance
401(k) Retirement Plan
Free Life Insurance
Sick Time Off
Certifications
Mentorship Program
Referrals
Family and Wellness benefits
Continuous Growth and Career Development
Company
Kaygen, Inc.
Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation.
51-200 employees
H1B Sponsorship
Kaygen, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (2)
2022 (3)
2021 (8)
2020 (16)
Funding
Current Stage
Growth StageLeadership Team
Anshul Chaturvedi
Founder & CEO
Rashmi Chaturvedi
Co-founder & President
Company data provided by crunchbase