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 DeltaV, 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 DeltaV.
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 ValGenesis, 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.
