Job Description Insight Global is looking to hire a Computerized System Validation (CSV) SME to sit in a hybrid environment in Frederick or Gaithersburg, MD. This individual will be responsible for technical authority and governance for the validation of GxP-impacting computerized systems throughout design maturation, configuration, integration, and readiness for commissioning and qualification. The role ensures systems are specified, engineered, and documented to meet regulatory requirements, data integrity principles, and lifecycle control, enabling a right-first-time start-up and handover to Operations and Quality. Key responsibilities include: - Validation Strategy & Planning: Develop and maintain system-level and project-level CSV strategies aligned with corporate procedures and industry standards (GAMP 5, ICH Q9/Q10, 21 CFR Parts 11/210/211, EU Annex 11). Define validation scope, risk-based approach, deliverables, and acceptance criteria. - Requirements & Traceability: Ensure clear, testable URS and functional/design specifications for automated and IT/OT systems. Establish robust Requirements Traceability Matrices (RTM) linking URS to design, configuration, and testing. - Risk-Based Validation: Lead or facilitate computerized system risk assessments (functionality, data integrity, cybersecurity, patient/product impact) to drive appropriate validation activities and documentation. - Design Reviews & Defect Prevention: Participate in detailed design reviews for DCS/PLC, BAS/EMS, historians, MES, LIMS, QMS, and auxiliary systems. Influence architecture, configuration management, and segregation to prevent late-stage rework. - Documentation Governance: Author, review, and approve CSV deliverables including validation plans, test strategies, configuration specifications, IQ/OQ/PQ protocols, test scripts, deviation handling, summary reports, and SOPs. - Configuration & Change Control: Define and enforce configuration management, version control, and change control for software, firmware, and automation code. Ensure auditable builds, release notes, and rollback procedures. - Testing Excellence: Oversee test readiness, environment control, data sets, and execution quality. Drive defect triage, retest strategy, and evidence standards (screenshots, audit trails, electronic records with attribution/timestamp). - Data Integrity by Design: Embed ALCOA+ principles, access controls, audit trails, time synchronization, backup/restore, disaster recovery, and archival requirements. Challenge designs that risk integrity or traceability. - Cybersecurity Alignment: Coordinate with IT/OT security to integrate security controls, user management, patching, hardening baselines, and network segmentation into the validated state without compromising compliance. - Supplier & SaaS Oversight: Assess supplier development/quality practices, review SaaS/Cloud validation packages, and define expectations for vendor documentation, testing evidence, and support models. - Regulatory Readiness: Ensure systems and documentation are inspection-ready. Support mock audits, gap closure, and responses to regulatory queries. - Integration with CQV: Align CSV activities with Commissioning & Qualification (CQV) schedules and deliverables. Coordinate handoffs between automation testing and equipment qualification to avoid duplication and gaps. - Training & Coaching: Train project teams on CSV methods, templates, and tools. Mentor engineers and integrators to improve specification quality and test coverage. - Metrics & Continuous Improvement: Define KPIs (defect density, test coverage, rework rate, schedule adherence) and drive continuous improvement through standard templates and reusable test asset libraries. - Handover & Lifecycle Management: Define release criteria for operational readiness. Ensure robust ongoing control through periodic reviews, incident/deviation & CAPA linkage, revalidation triggers, backup verification, and disaster recovery tests. Compensation: $75.00/hr to $85.00/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements - Education: Bachelor’s or master’s in engineering (automation, electrical, computer), computer science, or a related life science/technical field. - Experience: 8–12+ years in CSV/CSA for pharmaceutical/biotech GxP systems with significant involvement in detailed engineering, integration, and start-up of capital projects. - Technical Expertise: Deep knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+), risk management (ICH Q9), and validation deliverables. Familiarity with automation platforms (DeltaV, Rockwell, Siemens), BAS/EMS, MES, LIMS, QMS, historians, and laboratory computerized systems. - Tools and Methods: Proficiency with requirements management and test tools (e.g., Azure DevOps, HP ALM, JIRA), document control, and electronic validation repositories; capable of reviewing functional specs, design specs, logic narratives, and code/config snapshots. - Soft Skills: Strong technical writing, stakeholder engagement, influence without authority, and ability to balance compliance, schedule, and business value. - Relevant certifications (e.g., ISPE GAMP, PMP for project interface, CISA/CISSP for security awareness) - Biologics/GMP Facilities: Validation of process control for upstream/downstream equipment, clean utilities, environmental monitoring, and data flows to MES/LIMS. - Cloud/SaaS Validation: Experience validating SaaS systems and hybrid architectures, including supplier audits and shared responsibility models. - Electronic Records/Signatures: Implementation and testing of Part 11 controls, audit trails, and e signature workflows. - Integration and Interfaces: Validation of interfaces (OPC, web services, ETL) and data pipelines, with robustness to network segmentation and cybersecurity controls.