GxP CSV Specialist – Clinical and Validation testing SME
We are seeking a knowledgeable and detail-oriented GxP CSV Specialist to serve as either a Business Analyst or Subject Matter Expert (SME), supporting validation efforts for GxP-regulated computer systems. The ideal candidate will have strong experience with Computer System Validation (CSV) principles, 21 CFR Part 11 compliance, Annex 11, and the GAMP 5 framework. This role will be responsible for ensuring that systems used in clinical, manufacturing, or quality environments are validated, documented, and compliant with regulatory requirements. Plus, will provide subject matter expertise on clinical operations, quality standards, and regulatory expectations for GxP-aligned orchestration system design and implementation.
The unit supports healthcare technology delivery across the organization by collaborating with business units and Centers of Excellence. It provides domain-specific expertise and builds a specialized tech stack focused on Data Engineering, BI, and Analytics. The unit ensures compliance with HIPAA and promotes interoperability through HL7 FHIR standards. It plays a key role in delivering scalable, secure, and globally coordinated healthcare solutions.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Information Systems, Engineering, or a related field.
- 5+ years of experience working in GxP-regulated environments, with direct responsibility for Computer System Validation.
- Strong working knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and other regulatory guidance (e.g., FDA, EMA).
- Experience writing validation documentation and leading validation efforts for enterprise systems (e.g., LIMS, EDMS, ERP, CTMS, eTMF).
- Familiarity with SDLC methodologies, change control, and quality management systems (QMS).
- Ability to work independently and manage multiple validation projects simultaneously.
Nice-to-haves
- Experience with cloud-based SaaS solutions subject to GxP requirements.
- Prior involvement in regulatory inspections (e.g., FDA, MHRA) or audit preparation.
- Working knowledge of data integrity principles and ALCOA+ framework.
- Certification in CSV, QA, or GxP compliance (e.g., ISPE, PDA).
Core Responsibilities
- Act as a validation lead or advisor for computer systems used in GxP-regulated environments (e.g., LIMS, ERP, MES, eQMS, eTMF).
- Define and document validation strategy, scope, and deliverables in accordance with GAMP 5 and risk-based validation approaches.
- Collaborate with IT, QA, and business stakeholders to ensure systems meet compliance and business requirements.
- Write and review validation documentation, including URS, FRS, Risk Assessments, IQ/OQ/PQ, traceability matrices, and validation reports.
- Ensure systems comply with 21 CFR Part 11, Annex 11, and relevant GxP standards.
- Participate in vendor assessments and audits, ensuring third-party systems are appropriately validated.
- Review and align workflows to clinical trial protocols and commercial SOPs.
- Define and review QA checkpoints and quality gates.
- Ensure alignment with CoI/CoC processes, patient safety, and data integrity.
- Support URS and risk assessment development for validation.
- Guide GxP-compliant documentation and system implementation.
- Collaborate with IT and product teams on audit trail and logging requirements.
- Support test script review from a compliance standpoint.
- Represent QA during inspections and internal audits.
- Define deviation and change management workflows.
- Provide expert input for training, onboarding, and digital QA controls.
Soft Skills
- Excellent documentation and organizational skills.
- Strong communication and stakeholder engagement abilities.
- Detail-oriented mindset with a strong sense of ownership.
- Ability to balance regulatory compliance with pragmatic business needs.
What we offer
- Continuous learning and career growth opportunities
- Professional training and English/Spanish language classes
- Comprehensive medical insurance
- Mental health support
- Specialized benefits program with compensation for fitness activities, hobbies, pet care, and more
- Flexible working hours
- Inclusive and supportive culture
About Us
Established in 2011, Trinetix is a dynamic tech service provider supporting enterprise clients around the world.
Headquartered in Nashville, Tennessee, we have a global team of over 1,000 professionals and delivery centers across Europe, the United States, and Argentina. We partner with leading global brands, delivering innovative digital solutions across Fintech, Professional Services, Logistics, Healthcare, and Agriculture.
Our operations are driven by a strong business vision, a people-first culture, and a commitment to responsible growth. We actively give back to the community through various CSR activities and adhere to international principles for sustainable development and business ethics.
To learn more about how we collect, process, and store your personal data, please review our Privacy Notice: https://www.trinetix.com/corporate-policies/privacy-notice
