Job Details

Overview

The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors.

Roles & Responsibilities

• 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology.
• Strong understanding of GxP regulations, 21 CFR Part 11, FDA, and other industry-specific regulations.
• ERP experience: validating ERP systems; understanding CSA methodology and ensuring compliance and quality in software validation practices.
• Risk assessment methodologies (Low/Medium/High Risk) and validation and compliance procedures.
• Experience in system validation (hardware and software) and lifecycle management.
• Hands-on experience with risk assessments, gap analysis, and validation protocols (IQ, OQ, PQ).
• Familiarity with software testing tools, validation management software, and project management tools.
• Ensure the qualification and validation of computer systems, software applications, and automated processes for compliance with internal and external regulations (e.g., FDA, EMA, GxP, 21 CFR Part 11).
• Lead CSA activities, including risk assessments, gap analysis, and system lifecycle management, ensuring that systems are in compliance and operating within defined parameters.
• Develop and review validation protocols (e.g., IQ, OQ, PQ) and documentation, ensuring they meet quality standards and regulatory requirements.
• Review system documentation (specifications, user manuals, etc.) to ensure they are in line with regulatory requirements.
• Conduct periodic system reviews, re-validations, and updates to ensure compliance during system lifecycle stages.
• Perform hands-on testing, including functional, performance, and security testing of validated systems, documenting findings and actions for resolution.
• Strong organizational and documentation skills; excellent interpersonal skills, with the ability to work effectively in cross-functional teams.
• Provide recommendations and guidance for process improvement to mitigate risk and improve compliance.
• Ensure compliance with data integrity and electronic records management standards.
• Support audit and inspection activities, including preparing and reviewing documents and evidence required for regulatory and internal audits.
• Maintain knowledge of current industry standards, regulations, and best practices related to CSA and computer system validation.