The CSV Engineer (Computer System Validation Engineer) is 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.
- Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.
- 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 analytical instruments used in production areas.
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.
- 5+ Years 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.
- Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
- Ability to work independently and manage multiple projects simultaneously.
- Knowledge of software development life cycle (SDLC) and change control processes.
- Understanding of data integrity principles and practices.
- Experience on Sterile Drug Product manufacturing and associated equipment / utilities /laboratory instruments / IT Infrastructure. enterprise systems.
- Experienced in computer systems validation (CSV) from requirements to through release of analytical instruments used in Quality Control (QC) laboratories or in manufacturing operations as part of Process analytical Technology (PAT).
- Experienced in computer systems validation (CSV) of server / database-based laboratory software, middleware and enterprise applications, for example LIMS, Empower, NuGenesis.
- Completion of Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for analytical instruments and software systems.
- Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM
