CSV Engineer
Location: Dublin, Ireland (Onsite)Contract Duration: 12 Months
Take ownership of critical computerized systems as a CSV Engineer, ensuring they are validated, maintained, and compliant in high‑stakes sterile manufacturing environments.
Key Responsibilities
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computer systems and software applications.
Qualify manufacturing automation systems such as Delta V, MES, and other enterprise systems.
Collaborate with IT, Quality Assurance, and Operations to ensure compliance with regulatory guidelines and internal policies.
Work with vendors and suppliers to meet validation requirements for third‑party systems.
Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
Create and maintain validation documentation, including 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 system changes and executing appropriate validation activities.
Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
Stay current with industry trends, regulatory updates, and advancements in computer system validation practices.
Support regulatory inspections and audits by providing documentation and participating in discussions related to computer system validation.
Education & Experience Requirements
Bachelor's degree in Computer Science, Engineering, or a related field.
5+ years of experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
Experience with sterile drug product manufacturing and associated equipment, utilities, laboratory instruments, and IT infrastructure enterprise systems.
Experienced in computer systems validation (CSV) from requirements through release of SCADA/PLC‑controlled equipment (filling lines, isolators, lyophilizers).
Experienced in computer systems validation (CSV) of Emerson Delta V.
Technical & Regulatory Knowledge
Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Understanding of data integrity principles and practices.
Completion of Electronic Records/Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment and utility systems.
Familiarity with validation methodologies, including risk‑based validation approaches.
Proficiency in creating and executing validation protocols and documenting validation activities.
Knowledge of software development life cycle (SDLC) and change control processes.
Experienced in the use of paperless validation and test tools, such as Val Genesis, Kneat, and ALM.
Core Skills & Competencies
Excellent analytical and problem‑solving skills, with strong attention to detail.
Strong communication and interpersonal skills to collaborate effectively with cross‑functional teams.
Ability to work independently and manage multiple projects simultaneously.
Take charge of high‑stakes computerized systems as a CSV Engineer - validate, maintain, and ensure sterile manufacturing is always compliant and audit‑ready.
By submitting your details you agree to our TNC.
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