- Location
- Frankfurt am Main, Germany
- Type
- Full-time
- Department
- Engineering
- Seniority
- Lead
- Closing date
- Today
- Source
- Workday
Description
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position overview
The HVAC Lead – Clean Concept is the technical workstream leader responsible for the full design, engineering, procurement, construction, commissioning, and qualification of all HVAC systems and cleanroom environments within a major pharmaceutical capital project (€1 billion). This role ensures that all HVAC and clean concept solutions comply with GMP regulations, Sanofi global engineering standards, and HSE requirements, while meeting energy efficiency and carbon neutrality targets.
Main responsibilities:
- Lead the HVAC & Cleanroom design workstream end-to-end—from feasibility through qualification (C&Q)—covering all cleanroom classifications (ISO 5–8 / EU GMP Grade A–D) and defining the Clean Concept (room classification, pressure cascades, airlock design, contamination control strategy)
- Ensure compliance with Sanofi global standards for cleanroom design, HVAC energy optimization, air flow/air change rates, and environmental barriers (RABS/isolators), while overseeing design of AHUs, HEPA filtration (H13+), pressurization, temperature/humidity control, and containment strategies
- Coordinate technical delivery with EPC contractors and engineering firms, reviewing and approving HVAC specifications, P&IDs, datasheets, and FAT/SAT protocols, including HVAC automation (PLC/BMS) design
- Drive system integration across process, utilities, instrumentation, and BIM teams to ensure seamless 3D integration of HVAC systems into the overall building model
- Champion Energy & Sustainability goals by applying Carbon Neutral Design principles (optimized air recycling, energy-efficient equipment selection) and ensuring alignment with Sanofi's CO₂ reduction targets and zero fossil primary energy design where applicable
- Own HSE & GMP compliance throughout the project lifecycle (Phase 0–8), including pharmaceutical dust emission management, occupational hygiene controls for APIs, and participation in Pre-Start HSE Reviews (PSSR)
- Manage the HVAC workstream schedule, budget, and reporting, tracking contractor progress, managing scope changes, and presenting status updates to the Engineering Project Manager and Project Steering Committee
- Oversee FAT/SAT testing for all HVAC equipment to ensure readiness for qualification and handover
- Serve as the single point of contact for all HVAC/Clean Concept topics, liaising with Quality, HSE, Operations, Regulatory Affairs, and the site HSE Manager/Business Partner to validate design choices
About you
Education/Experience: advanced Engineering degree in HVAC, Mechanical, Chemical, Bioprocess Engineering or equivalent; relevant experience in HVAC engineering for pharmaceutical or biotech manufacturing facilities, preferably in a lead/workstream leader role on large capital projects (>€100M)
Soft and technical skills: Deep understanding of EU GMP Annex 1, ISO 14644, FDA cGMP, and Sanofi global engineering standards; experience with BIM/Revit MEP, AutoCAD, Primavera P6 or equivalent scheduling tools, BMS/SCADA systems advantageous
Languages: proficiency in English required; German and additional languages welcome
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, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€79.104,00 - €118.656,00Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.