The CSV Engineer (Computer System Validation Engineer) is responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices. This is a full-time onsite hourly rate contract position.
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 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.
- 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.
- 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 / IT Infrastructure. enterprise systems.
- Experienced in computer systems validation (CSV) from requirements to through release of SCADA / PLC controlled equipment (i.e. filling lines, isolators, Lyophilisers)
- Experienced in computer systems validation (CSV) of Emerson DeltaV.
- Experienced in computer systems validation (CSV) of MES.
- Completion of Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment/utility systems.
- Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM
