Validation, Commissioning and Capex Engineer

• Location: Amsterdam (hybrid model of working, 50/50)
• Job type: Permanent, Full time

About the job

Our team

The Amsterdam site is part of the global Sanofi CMC research and development organisation with sites all over the world. The Amsterdam Site currently has around 100 employees situated in Amsterdam, EU and America. It is a small biotech manufacturing and research facility with warehouse, laboratories, and cleanrooms. As a Validation, Commissioning and Capex Engineer you are part of the safety maintenance, engineering and facilities team on the Amsterdam site and you will be responsible for validating/qualifying equipment, systems and/or processes. Your Key stakeholders will be the quality department, production, warehouse and QC laboratory. You work closely with the facility coordinator, maintenance engineers and are flexible to stand in whenever needed.

Main responsibilities

• Designs, documents, manages, inspects, calibrates, tests and modifies the Capex-budget, instrumentation, equipment, mechanics and procedures used to manufacture or test various products to meet company requirements
• Ensure all systems and services comply with maintenance and safety regulations and are running correctly and efficiently to produce controlled products
• Investigate the causes of equipment failures and anomalies and decide if the equipment needs to be repaired or replaced
• Help to demonstrate systems or processes are performing as expected and operate within regulations to ensure data integrity and the production of quality products
• Creating/modifying and owning SOPs related to equipment/facility/utilities
• Developing and testing design specifications
• Monitoring and testing equipment/facility/utility
• Analysing and documenting test results
• Preparing compliance reports
• Directing validation & qualification activities
• Resolving testing problems
• Making adjustments or improvements to equipment and processes
• Creating databases to track validation activities
• Interpreting customer requirements
• Developing qualification & validation schedules, including re-qualification as needed
• Conducting training and overseeing the work of maintenance engineers and external technicians
• SME for both departmental and site qualification and validation issues
• CSV for which IT department is responsible
• Purchase of Capex related equipment, facility adaptations and utilities

About you

• Experience in an international Pharma/GMP environment preferable in cell therapy or Food industry
• You are an excellent organizer and communicator who thinks ahead, knows how to prioritize and executes tasks in accordance with the timelines.
• Analytical and problem solving skills
• Good command of English language (both written and oral), preferable Dutch as well. Working language will be English.
• Good knowledge of MS Office and worked on a regular basis in an electronicQMS
• You are familiar with applicable pharmaceutical standards both in Europa (EMA) as in America (FDA) like Eudralex, Pharmacopea, ATMP, ISPE, etc.
• You promote a proactive, client focused and solution-focused approach and escalates any issues to the Sr. Dir EMF

Pursue progress. Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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