Τhe position holder will be required to:

• Act on behalf of Group Quality during implementation projects of enterprise computerized systems, process and packaging equipment or site services
• Provide support to Famar business and functional units as a subject matter expert for qualification of equipment and computerized systems validation
• Contribute to the development and improvement of the quality system documentation.

The CSV Engineer will act as the main point of contact for validation within group quality and the various project teams and departments within FAMAR.

DUTIES AND RESPONSIBILITIES:

• Execute CSV activities for the implementation projects of enterprise computerized systems, process and packaging equipment and site services and to ensure the compliance of such projects with company policies, guidelines and SOP’s as well as the rules and regulations related to the manufacture of medicines
• Manage validation service vendors to ensure that the services provided meet regulatory expectations
• Exhibit a high level of knowledge and be able to provide technical and validation support to FAMAR business units. This includes proposals of suitable solutions that can be implemented by the sites
• Provide validation / qualification training to business units

 CANDIDATE’s PROFILE/ SKILLS:

• Bachelor and/or Master’s Degree in the area of Engineering, Chemistry or Computer Science
• At least five years’ experience with qualification and validation of computerized systems, process-packaging equipment, laboratory instruments and site services in the pharmaceutical industry. Includes automation systems utilizing PLC/ HMI
• Must be fluent in English (advanced verbal and written skills). Knowledge of Italian or Spanish language will be considered an advantage

Advanced computer skills (MS Office, Word, Excel, PowerPoint, Teams); advanced familiarity with MS Excel (analyzing spreadsheets and charts). Knowledge of MS Project and Visio will be considered an advantage

Qualifications

• Full knowledge of regulations related to CSV and Validation/ Qualification according to EudraLex Volume 4, Annex 11 and Annex 15 and applicable regulations such as 21 CFR Part 11
• Familiarity with GAMP engineering and CSV best practices such as good automated manufacturing practice (GAMP version 5) and good practices for computerized systems in regulated GxP environments, (PIC/S PI-011/3).
• Experience in the management of validation/ qualification projects, or as working as part of a project team, related to introduction of processing and packaging equipment, site services and environmental control units in pharmaceutical production sites.
• Experience with projects related to the introduction of enterprise or local software applications that require computerized systems validation
• Experience of writing validation life cycle documentation, (Validation plans, risk analysis, design documentation, qualification protocols etc.)
• Previous experience in an engineering or quality assurance function related to validation is required
• Strong written and verbal communication skills (ability to present complex information to others clearly and logically)
• Must be able to demonstrate strong project management skills, (planning, prioritization, problem solving and follow up)
• Must have good team working skills and be able to build constructive relationships with vendors and colleagues
• Manage time effectively in order to meet targets
• Experience working at an aseptic production site will be considered beneficial
• Optimal reporting and alerting capabilities
• Work effectively on a number of projects simultaneously
• Work to a high quality standard and possess a high level of attention to detail