Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
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
a. Site Subject Matter Expert, SME, for computer system validation.
b. Ensure local site computer systems and their interfaces are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
c. Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
d. Author and when required review qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports
e. Execute qualifications across the site, including QC, production, warehouse, facilities, equipment, utilities and local site computer system qualifications, excludes global IT systems.
f. Execute validations for processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
g. Participate to the development and maintenance of the local site procedures
h. Participate to risk assessments and risk management teams
i. Review change controls to evaluate impact on qualified systems and validated processes
j. Develop and justify the qualification & validation approach based on risk and a scientific rational
k. 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.