Role: Validation Engineer Lead
Location: Schaumburg, IL (Onsite)

Job Description

The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin business leadership and CSV System stakeholders.

Responsibilities

• Lead and oversee the Validation and Qualification processes for GxP Computer Systems and infrastructure, to ensure adherence to 21 CFR Part 11 Compliance, GAMP-5, EU Annex 11, and other relevant regulations.
• Recommend and review system-level configuration to fulfill security, data integrity, and regulatory requirements.
• Design Configuration Specifications (CS) in sandboxes and implement them into Validated Systems.
• Write, review, and approve CSV assessment documents, including GxP Computer System Risk Assessments, Part 11 Annex 11 Compliance Assessments, and GxP Computer System Data Integrity Assessments.
• Lead installation and testing activities including writing and overseeing Installation Qualification (IQ) Protocol and scripts, Operational Qualification (OQ) Protocol and scripts, Performance Qualification (PQ/UAT) Protocol and scripts, and Requirements Traceability Matrices (RTM).
• Author and approve Validation Plans and Validation Summary Reports.
• Document, evaluate, manage, and log GxP Computer System Change Control Requests (CCRs).
• Maintain an inventory of GxP Computer Systems, assess Validation status, and prioritize actions based on risk.
• Retire and archive IT GxP Computer Systems including retirement/migration planning and writing retirement summary reports.
• Provides input into IT procedures, Work Instructions (WIs), Guidance Manuals (GMs), and training materials for developing, maintaining, and using GxP Computer Systems.
• Evaluates potential new Computer Systems or software for GxP impact and provide risk-based Validation guidance.
• Review incidents and changes to Computer Systems for GxP impact, identifying and executing necessary Validation or Qualification requirements.
• Conduct and perform periodic reviews of GxP Computer Systems and user access to ensure ongoing compliance with regulatory standards and readiness for audits.
• Performs and/or assists with Qualification Audits of GxP IT System Service Providers to ensure that these organizations are operating in a compliant manner and maintaining the required quality standards.
• Maintain Master Validation Plan for company computerized systems.
• Develops / improves validation programs as needed to remain current with cGMPs and industry standards
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot, and maintain systems, equipment and processes.
• Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).

Requirements

• Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations).
• Bachelor's degree or equivalent experience in computer science, information technology, or a related field.
• Minimum of 5 year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products.
• Installation, Operational and Performance Qualification protocol generation and execution experience
• Excellent technical writing and verbal communication skills.
• Good communication skills and leadership skills.
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• High degree of proficiency in Microsoft Office Suite and Smartsheet
• Detail-oriented with a strong analytical mindset and problem-solving capabilities
• Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously