Computer Systems Validation Engineer

Job Title: Computer Systems Validation Engineer (CSV Engineer)

Location: Ireland

About Our Client:

Our client is a leading player in the Medical Device and Pharmaceutical industry, committed to ensuring the highest standards of quality and compliance in their products and processes. They are currently seeking a skilled and dedicated Computer Systems Validation Engineer to join their dynamic team and contribute to their mission of delivering safe and effective medical solutions.

Job Summary:

As a Computer Systems Validation Engineer, you will be responsible for ensuring that all computer systems and software used within the organization are validated in accordance with regulatory requirements and industry best practices. You will play a vital role in maintaining compliance with applicable regulations such as FDA, ISO, and GxP standards, while also collaborating with cross-functional teams to support the development and maintenance of computer systems.

Key Responsibilities:

- Lead and execute computer systems validation activities, including the development and execution of validation plans, protocols, and reports for software and computer systems.

- Collaborate with project teams to define validation requirements and ensure that all systems are compliant with regulatory standards and internal policies.

- Perform risk assessments and analysis for computer systems, identifying key areas for validation and mitigation of potential issues.

- Conduct assessments and reviews of system changes, ensuring all modifications undergo appropriate validation as per standard operating procedures.

- Liaise with stakeholders, including IT, Quality Assurance, and Operations teams, to ensure seamless integration and understanding of validation processes.

- Prepare and maintain comprehensive documentation related to validation activities, ensuring traceability and compliance for audits and inspections.

- Support internal audits and regulatory inspections by providing validation-related information and addressing queries.

Qualifications:

- Minimum of 4 years of experience in computer systems validation within the Medical Device or Pharmaceutical industry.

- Strong understanding of regulatory requirements (e.g., FDA, ISO, GxP) and relevant industry standards.

- Proven expertise in validation methodologies, including IQ, OQ, and PQ.

- Experience with electronic documentation systems (e.g., eQMS, LIMS) and software applications commonly used in regulated environments.

- Excellent analytical and problem-solving skills, with a strong attention to detail.

- Strong communication and interpersonal skills, able to work collaboratively with cross-functional teams.

- Relevant degree in Engineering, Computer Science, or related field is preferred.

Application Process:

Please submit CV to harry.miles@sourcingsegments.com 

Alternatively through link at www.sourcingsegments.com/jobs

---

Sourcing Segments Group is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.