CSV Consultant; Pharma

This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$83.00/hr - $101.00/hr

• Bachelor’s or master’s in engineering (automation, electrical, computer), computer science, or a related life science/technical field.
• 8–12+ years of experience in CSV/CSA for pharmaceutical/biotech GxP systems with significant involvement in detailed engineering, integration, and start‑up of capital projects.
• 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 (Delta
  
  V, Rockwell, Siemens), BAS/EMS, MES, LIMS, QMS, historians, and laboratory computerized systems.
• Proficiency with requirements management and test tools (e.g., Azure Dev Ops, HP ALM, JIRA), document control, and electronic validation repositories; capable of reviewing functional specs, design specs, logic narratives, and code/config snapshots.
• 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.

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…