Global SME - Process Engineer (Drug Product) / Fill and Finish

Our client, a global leader in the pharmaceutical industry, is seeking an expert to define and develop technical standards for drug product equipment design across international manufacturing sites. The role focuses on optimizing the lifecycle of physical assets while ensuring strict adherence to global engineering, safety, and quality standards.

• Define and develop global technical standards for sterile drug product fill-finish equipment, including barrier technology and formulation systems.
• Provide technical expertise and conduct peer reviews for large-scale CAPEX projects to ensure optimal engineering solutions and compliance.
• Lead a global network of internal and external experts to monitor technological developments and implement innovations in equipment lifecycles.
• Draft and interpret complex technical documentation, including P&ID, PFD, and cost estimates for process-related investments.
• Act as the technical lead during safety and quality risk assessments such as HAZOP, QRA, and FMEA.
• Support the development of standards for drug substance manufacturing process systems and clean utilities such as WFI and purified water.
• Ensure the integration of environmental and safety aspects into all engineering guidelines and best practices.

• You have a Master's degree in Engineering or a related scientific field.
• You possess 8+ years of experience in industrial engineering with a focus on Sterile Drug Product Fill Finish Equipment, Barrier Technology, and Process Piping.
• You bring a strong knowledge of cGMP, FDA, ICH, and ISPE regulations and guidance documents.
• You have expertise in developing P&ID and PFD and working within EPC or EPCM contracting models.
• You're a proactive leader with excellent communication skills, capable of presenting to senior management and working in a matrix environment.
• You are fluent in English and French.

Nice to Haves

• Experience with verification and validation using V-cycle or ASTM E2500 approaches.
• Familiarity with Bio Safety Levels (up to BSL2) and ATEX protocols.

• Bénéficiez d'un package salarial compétitif avec des avantages supplémentaires qui récompensent votre talent.
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