CSV Engineer

CREGG; Galway; On-site; EUR 60,000 - 90,000; Full time

Job summary

CREGG in Galway is seeking an experienced CSV Engineer to join a leading medical device organisation. The role focuses on Computer System Validation, software validation and quality assurance within a regulated environment.

You will lead validation activities across CSV processes, develop and execute validation protocols, and contribute to audits and continuous improvement of CSV/CQV procedures.

Qualifications

• 5+ years' experience in Computer System Validation, CQV, software validation or related validation/quality engineering role.
• Proven experience in medical device industry or highly regulated manufacturing.
• Strong knowledge of CSV and software validation methodologies.
• Experience with IQ/OQ/PQ and validation lifecycle activities.
• Experience developing validation protocols, reports and supporting documentation.
• Knowledge of FDA and EU regulatory requirements for medical devices.

Responsibilities

• Lead and support CSV activities across regulated systems and software applications.
• Prepare and review URS, functional specs, risk assessments, validation plans and traceability matrices.
• Develop and execute software validation protocols with proper documentation.
• Perform risk-based validation assessments for computerized systems.
• Support validation and implementation of GxP and quality-critical systems in manufacturing.
• Ensure compliance with FDA, EU and GxP data integrity principles.
• Manage change controls, deviations, CAPAs and non-conformances for validated systems.
• Collaborate with Quality, IT, Engineering, Manufacturing, Automation and Operations teams.
• Support system upgrades, migrations, integrations and new implementations while maintaining validated state.
• Participate in audits, providing validation documentation and technical support.

Skills

CSV expertise

Software validation

Quality assurance

Regulatory compliance

Documentation skills

Risk-based validation

Cross-functional collaboration

Analytical thinking

Education

Engineering/CS/IT degree

Job description

Location: Galway
Industry: Medical Devices
Area: Quality Software Validation

Job Overview

We are seeking an experienced CSV Engineer to join a leading medical device organisation in Galway. The successful candidate will have a strong background in Computer System Validation (CSV), software validation and quality assurance within a regulated medical device environment.

This role will be responsible for supporting the validation of computerised systems, software applications, equipment and processes, ensuring compliance with applicable regulatory requirements and company quality standards.

Responsibilities

• Lead and support Computer System Validation (CSV) activities across regulated systems and software applications
• Prepare and review URS, functional specifications, risk assessments, validation plans and traceability matrices.
• Develop and execute software validation protocols, ensuring appropriate documentation and evidence is generated.
• Perform computerised system risk assessments and ensure validation activities are appropriately risk-based.
• Support the validation and implementation of GxP and quality-critical computerised systems within a medical device manufacturing environment.
• Ensure validation activities comply with relevant FDA, EU and medical device regulatory requirements, as well as applicable GxP and data integrity principles.
• Manage and support change controls, deviations, CAPAs and non-conformances associated with validated systems.
• Work closely with Quality, IT, Engineering, Manufacturing, Automation and Operations teams to ensure successful system implementation and validation.
• Support software/system upgrades, migrations, integrations and new system implementations, ensuring validated state is maintained.
• Participate in internal and external audits, providing validation documentation and technical support as required.
• Support the development and continuous improvement of CSV/CQV procedures, standards and validation processes.

Requirements

• 5+ years' experience in Computer System Validation, CQV, software validation or a related validation/quality engineering role.
• Proven experience working within the medical device industry or another highly regulated manufacturing environment.
• Strong knowledge of CSV and software validation methodologies.
• Practical experience with CSV, IQ/OQ/PQ and validation lifecycle activities.
• Experience developing and executing validation protocols, reports and supporting documentation.
• Strong understanding of risk-based validation approaches.
• Experience with change controls, deviations, CAPA and non-conformance management.
• Knowledge of FDA and EU regulatory requirements relevant to medical device manufacturing.
• Understanding of GxP, data integrity and electronic records/electronic signatures.
• Strong technical writing and documentation skills.
• Excellent communication skills with the ability to work effectively across Quality, IT, Engineering and Manufacturing functions.
• Strong analytical, problem-solving and organisational skills.
• Experience with 21 CFR Part 11 and electronic records/electronic signatures.
• Knowledge of EU GMP Annex 11 and GAMP 5 principles.
• Experience validating MES, ERP, LIMS, SCADA, PLC/automation or other manufacturing systems.
• Experience supporting new system implementation, upgrades and system integrations.
• Experience in a Quality Assurance or Quality Validation function within medical devices.
• Relevant degree in Engineering, Computer Science, IT, Quality, Science or a related discipline.