Technical Sub-Project Manager providing leadership in clean utility projects within the pharmaceutical sector. Overseeing engineering design, project execution, and compliance with regulatory standards.
Responsibilities
Provide end-to-end technical leadership for the engineering, design, and qualification of complex clean utility systems (WFI, PW, Pure Steam, Clean Gases).
Lead the clean utility scope in large multidisciplinary CAPEX projects from conceptual design through to handover.
Act as the technical authority and System Owner, defining system architecture, design philosophy, and lifecycle strategies.
Develop and approve technical specifications, URS, P&IDs, layouts, and automation concepts.
Ensure robust hygienic design, including material selection, slope concepts, and microbial control strategies.
Manage sub-project budgets, schedules, and resources while coordinating external EPC partners and system suppliers.
Lead CQV activities, including the planning and execution of DQ, FAT, SAT, and IQ/OQ protocols.
Drive value engineering and operational excellence to ensure high-quality and cost-effective project delivery.
Evaluate and introduce innovative technologies such as membrane-based WFI generation and digital predictive maintenance.
Requirements
Bachelor’s or Master’s degree in Mechanical, Chemical, or Process Engineering.
7 years or more of experience in the pharmaceutical, biotechnology, or life sciences industry.
Extensive expertise in the design and delivery of WFI, PW, and Pure Steam systems, including distillation and membrane technologies.
Deep understanding of GMP, FDA, EMA, and Swissmedic regulations as well as hygienic design principles (ASME BPE).
Proven track record in managing sub-projects and external engineering firms within large-scale capital projects.
Proficient in English and German.
High willingness to travel (50% or more) and accept international assignments.
Benefits
Relocation benefits are not offered for this position.
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