CSV Engineer Contract
Location: Dublin, Ireland
Job Type: Contract (12 months)
Are you an experienced CSV Engineer passionate about ensuring the integrity and compliance of computerized systems in a cutting-edge pharmaceutical environment? We are looking for a dedicated professional to join our team on a contract basis, focusing on validating critical systems for sterile drug product manufacturing.
About the Role
As a CSV Engineer, you will play a pivotal role in validating and maintaining our computerized systems to meet stringent regulatory requirements and adhere to industry best practices. You will be instrumental in ensuring the reliability and compliance of our manufacturing automation systems, laboratory analytical instruments, and enterprise systems.
Key Responsibilities
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications.
- Work collaboratively with IT, Quality Assurance, and Operations teams to ensure adherence to regulatory guidelines and internal policies.
- Conduct risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
- Create and maintain comprehensive validation documentation, including validation plans, test scripts, traceability matrices, and validation summary reports.
- Perform periodic reviews to ensure ongoing compliance.
- Participate in change control processes, assessing the impact of system changes and overseeing appropriate validation activities.
- Provide expert guidance and support to project teams on CSV principles, best practices, and regulatory expectations.
- Stay up-to-date with industry trends, regulatory changes, and advancements in computer system validation.
- Collaborate with vendors and suppliers to ensure third-party systems meet validation requirements.
- Support regulatory inspections and audits, providing necessary documentation and participating in direct discussions.
- Perform qualification of laboratory analytical instruments (e.g., Cell Viability Analyzers, Liquid Handlers).
- Execute qualification of manufacturing automation systems (e.g., DeltaV, MES).
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.
- Strong knowledge of regulatory guidelines, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Familiarity with various validation methodologies, including risk-based approaches.
- Proficiency in creating and executing validation protocols and documenting all validation activities.
- Excellent analytical and problem-solving skills, with a keen eye for detail.
- Strong communication and interpersonal skills for effective cross-functional collaboration.
- Ability to work independently and manage multiple projects simultaneously.
- Knowledge of Software Development Life Cycle (SDLC) and change control processes.
- Solid understanding of data integrity principles and practices.
- Experience with Sterile Drug Product manufacturing and associated equipment, utilities, laboratory instruments, and IT infrastructure enterprise systems.
- Proven experience in computer systems validation (CSV) from requirements through to release of SCADA / PLC controlled equipment (e.g., filling lines, isolators, Lyophilisers).
- Direct experience with Emerson DeltaV CSV.
- Proficiency in conducting Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment/utility systems.
- Experience using paperless validation and test tools such as ValGenesis, Kneat, or ALM is highly desirable.
