CSV Engineer – Ref. 500MQ

  • Contract
  • Dublin

Headcount Solutions is seeking a CSV Engineer to join the team at a multinational client’s biotech facility in Dublin. The CSV Engineer will be responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices. Responsibilities:

· Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.

· Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.

· Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.

· Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.

· Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.

· Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.

· Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.

· Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.

· Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.

· Qualification of laboratory analytical instruments (e.g. Cell Viability Analysers, Liquid Handlers etc.)

· Qualification of manufacturing automation systems (e.g. DeltaV, MES etc.)

Requirements:

· Bachelor’s degree in Computer Science, Engineering, or a related field.

· Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

· Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.

· Familiarity with validation methodologies, including risk-based validation approaches.

· Proficiency in creating and executing validation protocols and documenting validation activities.

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

· Knowledge of software development life cycle (SDLC) and change control processes.

· Understanding of data integrity principles and practices.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

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