Design Manager - HME( hot melt extrusion) / Continuous Manufacturing

Design Manager - HME( hot melt extrusion) / Continuous Manufacturing Division

Job Summary:

Design Manager HME / Continuous Manufacturing Division

Key Responsibilities:

• Lead and oversee the design of

  Hot Melt Extrusion (HME) systems

  ,

  continuous granulation

  ,

  drying

  , and related pharmaceutical / food manufacturing equipment.
• Collaborate with R&D, sales, and process engineering teams to develop custom-engineered solutions based on client specifications and application requirements.
• Manage a team of mechanical design engineers and CAD professionals; ensure timely and high-quality delivery of design outputs.
• Prepare and approve detailed drawings, P&IDs, general arrangements, BOMs, and fabrication packages using modern 2D and 3D CAD tools (Solid Edge preferred).
• Ensure all designs meet applicable

  GMP

  ,

  FDA

  , and

  ISPE

  guidelines, as well as industry standards such as ASME, ISO, and CE.
• Drive design reviews, risk assessments (FMEA), and validation support for new product development and customer-specific projects.
• Support cross-functional teams during FAT, SAT, and troubleshooting activities related to mechanical design.
• Continuously improve product designs based on feedback, field data, and evolving pharmaceutical manufacturing requirements.

Qualifications & Experience:

• Bachelors degree in Mechanical / Process Engineering (Masters degree preferred).
• 8-10 years of relevant experience in mechanical design, with a strong background in pharmaceutical and food processing equipment.
• Deep understanding of

  Hot Melt Extrusion (HME)

  and

  continuous manufacturing principles

  used in pharmaceutical and food production.
• Proven track record in leading design teams and delivering complex capital equipment projects.
• Familiarity with GMP design principles, sanitary design, and pharmaceutical / food-grade materials and finishes.
• Strong leadership, communication, and documentation skills.

Preferred Experience:

• Experience in continuous oral solid dosage (OSD) processing, twin-screw extrusion, or modular equipment design.
• Exposure to pharma regulatory environments (FDA, EMA) and associated equipment validation processes (IQ/OQ/PQ).
• Experience working in an ETO (Engineer-to-Order) environment with high levels of customization.

What We Offer:

• A leadership role in a cutting-edge pharmaceutical technology division.
• Competitive compensation with performance-based incentives.
• Exposure to advanced processing systems and innovative drug manufacturing platforms.
• A collaborative work environment focused on quality, compliance, and innovation.