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Validation Engineer CSV - Switzerland  

Celgene (company)


Posted on : 26 December 2016

Project Description

  • 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 

QualificationsSkills/Knowledge Required  
  • 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.