- The CSV Engineer is the Couvet Manufacturing site subject matter expert for the qualification and validation of the site’s local computer systems.
- Additionally, this role shall perform qualification and validation activities for facilities, utilities, equipment and processes.
- The CSV Engineer assures compliance of these activities with cGMP as well as with internal policies and procedures.
- The CSV Engineer has demonstrated experience of managing validation projects, on time and within budget.
Duties and Responsibilities
- Site Subject Matter Expert, SME, for computer system validation.
- Ensure local site computer systems and their interfaces are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports
- Execute qualifications across the site, including QC, production, warehouse, facilities, equipment, utilities and local site computer system qualifications, excludes global IT systems.
- Execute validations for processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
- Participate to the development and maintenance of the local site procedures
- Participate to risk assessments and risk management teams
- Review change controls to evaluate impact on qualified systems and validated processes
- Develop and justify the qualification & validation approach based on risk and a scientific rational
- Project management of qualification and validation activities, including external vendors and internal departments
- BS in Engineering or Technical discipline
- Experienced in pharmaceutical qualification and validation; at a solid dosage plant is advantageous
- Proven ability to qualify and validate computer systems and their interfaces; knowledge of OSI PI, OPC, Laetus, RMS, Empower is an advantage
- Automation knowledge
- Familiarity with current Data Integrity & GxP requirements and best practices, including MHRA, WHO, FDA data integrity recommendations, 21 CFR part 11, 211, Annex 11, EU-GMP guidelines and GAMP
- Good communication skills in English with facility, production, laboratory, technical operations, QA, and outside vendor groups; French advantageous
- Team player: ability to interact effectively with team and customers
- Proven project management skills.