Job Title: CSV Engineer

Contract Length: 6 Months

Location/onsite requirements: Dublin, Ireland (Hybrid)
 

Job Overview: We are looking for a dedicated and experienced Computer System Validation (CSV) Engineer to join our team. This role is crucial for ensuring the compliance, validation, and operational efficiency of computerized systems in a regulated environment. The CSV Engineer will work closely with IT, quality, and engineering teams to ensure that all computer systems meet regulatory requirements and are functioning as intended according to Good Manufacturing Practices (GMP), 21 CFR Part 11, and other relevant standards.

Key Responsibilities:

• Lead and execute the validation lifecycle for computerized systems (COTS and custom) used in regulated environments.
• Develop, write, and review validation documentation including Validation Plans, User Requirements Specifications (URS), Design Qualifications (DQ), Risk Assessments, Validation Protocols (IQ/OQ/PQ), and Summary Reports.
• Perform risk assessments and gap analyses to ensure compliance with regulatory requirements and industry best practices.
• Collaborate with cross-functional teams to ensure proper configuration and implementation of validated computer systems.
• Execute IQ/OQ/PQ for computer systems, ensuring they are compliant with all regulatory standards (e.g., 21 CFR Part 11, Annex 11).
• Manage and document deviations, non-conformances, and CAPA (Corrective and Preventive Action) processes related to CSV activities.
• Ensure that the computerized systems are properly validated and maintain compliance throughout their lifecycle.
• Assist with the design, development, and review of system lifecycle documentation, ensuring all procedures are compliant with relevant regulatory standards.
• Ensure the effective and timely completion of all validation activities and system updates to maintain compliance.
• Support IT and system owners in maintaining validated status of systems and in performing system upgrades, patches, or enhancements while adhering to validation requirements.
• Provide ongoing support for change control and configuration management of validated systems.
• Stay up-to-date with the latest industry regulations, standards, and technologies relevant to computerized systems and validation practices.

Education & Experience Requirements:

• Education: Bachelor’s Degree in Computer Science, Information Technology, Life Sciences, or a related technical field.
• Experience: 3-5 years of experience in Computer System Validation within the regulated pharmaceutical, biotechnology, or healthcare industries.
• In-depth knowledge of 21 CFR Part 11, GxP, and other applicable validation and regulatory standards.
• Experience with validation tools, software, and protocols.

Skills & Qualifications:

• Strong technical writing skills with the ability to create clear, thorough, and accurate validation documentation.
• Experience with computerized system lifecycle management, including system design, development, implementation, and ongoing maintenance.
• Knowledge of risk-based approaches to validation and proficiency with risk assessment methodologies (FMEA, V-model, etc.).
• Ability to work effectively within cross-functional teams and communicate complex technical concepts clearly.
• Excellent problem-solving and troubleshooting skills, with a focus on ensuring compliance and system reliability.
• Strong organizational and project management skills, with the ability to prioritize multiple tasks effectively.
• Excellent communication skills, both verbal and written, and the ability to interact with various stakeholders.

Language Requirements: Proficiency in English (written and spoken).