LOCATION: Westlake Village, CA and various and unanticipated locations throughout the U.S. (Must be willing to work anywhere in the U.S. as the position may involve relocation to various and unanticipated client site locations; any relocation to be paid by employer pursuant to internal policy.)
DUTIES: Develop and implement CSV/CSA strategies ensuring compliance with GxP, 21 CFR Part 11, Annex 11, GAMP 5, and data-integrity requirements. Serve as subject matter expert providing technical and regulatory guidance for compliant system design and lifecycle controls. Oversee lifecycle validation activities for GxP systems including implementation, configuration changes, reviews, and decommissioning. Lead impact assessments to maintain regulatory and quality-system compliance. Author, review, and approve validation and quality deliverables. Maintain and enhance distribution quality-management processes to ensure adherence to applicable GxP regulations and international standards. Optimize distribution and quality-related technologies to strengthen data integrity, traceability, audit readiness, and operational performance within regulated environments. EOE
REQTS: Must have a Bachelor’s degree or foreign equivalent in Information Technology, Computer Science, or a related field plus five (5) years of experience in the position offered, as a Test Lead Validation Engineer, or a related position. Must have five (5) years of experience with all of the following: Designing ILM-driven data management architectures in Informatica to support regulated-data protection and compliance through standardized archiving, masking, and validation methodologies; Designing enterprise information governance frameworks on OpenText platforms in accordance with regulatory requirements by applying standardized discovery, classification, retention, and disposition controls that support GDPR, HIPAA, and SOX compliance; Engineering clinical-data management architectures across Oracle Inform, Oracle IRT, and Medidata Rave platforms in alignment with validated design, coding, and review methodologies to support study accuracy and regulatory compliance; Designing DocuSign-based electronic signature architectures in alignment with 21 CFR Part 11 through the application of standardized configuration and validation methodologies; Engineering governed BI architectures that support validated analytics and secure access controls across MicroStrategy and Cognos platforms through standardized modeling, performance-tuning, and verification methodologies; Leading GxP compliance initiatives by applying advanced CSV and SDLC validation methodologies incorporating risk-based assessment, controlled documentation practices, and regulatory-aligned lifecycle standards; and Managing quality system governance within ServiceNow by applying 21 CFR Part 11 compliant change management and deviation control frameworks aligned with GAMP 5 validation principles.
HOURS: Full-Time; Mon-Fri (40 hrs/week)
SALARY: $160,000 - $160,000 per year
Skills Required
- Bachelor's degree or foreign equivalent in Information Technology, Computer Science, or a related field
- Five years of experience in the position offered, as a Test Lead Validation Engineer, or a related position
- Five years designing ILM-driven data management architectures in Informatica
- Five years designing enterprise information governance frameworks on OpenText supporting regulatory controls (GDPR, HIPAA, SOX)
- Five years engineering clinical-data management architectures across Oracle InForm, Oracle IRT, and Medidata Rave
- Five years designing DocuSign-based electronic signature architectures aligned with 21 CFR Part 11
- Five years engineering governed BI architectures supporting validated analytics using MicroStrategy and Cognos
- Five years leading GxP compliance initiatives applying advanced CSV and SDLC validation methodologies
- Five years managing quality system governance within ServiceNow using 21 CFR Part 11-compliant change and deviation controls
- Willingness to work anywhere in the U.S. and relocate to unanticipated client site locations as required
What We Do
Agilisium is the #1 Data Innovation Lab Solutions & Services Company for Cloud Customers with a vertical focus on LifeScience & Pharma Industry. We focus on providing the Top 1% of Data Professionals ( Data Engineers, Data Analysts, BI, Data Scientists, MDM experts and so one..). Agilisium provides its customers with Top Quality Cloud and Data Professionals and we are working on building a 5000 Strong & Certified, Global Workforce We possesses Global Delivery Capabilities ( USA, Canada, Mexico, Argentina, Costa Rica, Columbia, UK, Netherlands, Bulgaria, Portugal, India, Nepal, Sri Lanka ) We primarily assist our clients and partners in two ways. #1 Assist them with Talent ( Providing them with Managed and Certified Speciality Talent across the geography) - We have our AWS Cloud Certified staff working from the following locations around the world, North America (US, Canada, Mexico), Central America ( CostaRica ), South America ( Argentina ), Asia ( India, Nepal, Sri Lanka ), EU ( UK, Netherlands, Portugal, Bulgaria, Poland ) #2 Assist with Consulting, Design, Development, and Implementation of AWS Cloud Data Projects
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