Design Lead

Role & responsibilities

Required Skills & Competencies / Key Responsibilities

• Lead the design and engineering of Pharmaceutical High Purity Water Systems, including Pretreatment,

Purified Water (PW), Water for Injection (WFI), Clean Steam, Decontamination, and

associated distribution systems.

• Prepare and review P&IDs, Process Flow Diagrams (PFDs), General Arrangement (GA) drawings,

equipment layouts, fabrication drawings, isometric drawings, equipment specifications, Bills

of Materials (BOMs), and other engineering documentation.

• Perform process calculations, hydraulic analysis, equipment sizing, piping design, and develop

technical solutions based on customer User Requirement Specifications (URS).

• Ensure all designs comply with ASME BPE, GMP, ISPE, FDA guidelines, 21 CFR Part 11, and other

applicable pharmaceutical engineering standards.

• Support Computer System Validation (CSV) activities, including Design Qualification (DQ), Installation

Qualification (IQ), Operational Qualification (OQ), Factory Acceptance Testing (FAT), and Site

Acceptance Testing (SAT).

• Coordinate with cross-functional teams including Sales, Projects, Procurement, Production, QA/QC,

Automation, and Commissioning to ensure successful project execution.

• Provide technical guidance during manufacturing, installation, commissioning, troubleshooting, and

design improvement activities.

• Use AutoCAD and 3D CAD software (SolidWorks or Inventor) to develop accurate engineering designs

and documentation.

• Lead design reviews, mentor junior engineers, and ensure engineering quality, compliance, and timely

project delivery.

• Demonstrate strong leadership, communication, client management, and project planning skills

while managing multiple projects to meet quality, cost, and delivery objectives

Preferred candidate profile

• Design Qualification documents.

• GA drawings and fabrication drawings.

• FAT/SAT protocols.

• To approve the vendor documents

• IQ & OQ protocols.

• Design qualification of the water systems

• Detailed drawings of vessels and heat exchangers and other components.

• Validation documents for the water systems

• Documentation for automation.

• Skid Fabrication activities.