Mechanical Design Manager

Drishti Consultants; Pune District; On-site; INR 2,000,000 - 5,200,000; Full time

Job summary

Drishti Consultants seeks an experienced engineering leader to steer design and process development in sterile manufacturing, liquid/ointment suites, and bioprocess systems. You will direct product design, mechanical systems, utilities, and automation integration aligned with industry standards and regulatory requirements.

Lead cross-functional teams, review P&IDs, BOMs, and project plans; drive on-time delivery and quality across design, FAT/SAT, commissioning and handover.

Job description

Role & responsibilities:

• Lead the engineering strategy across multiple projects and teams in sterile manufacturing, liquid/ointment suites, and process systems.
• Provide technical direction for product design, mechanical systems, utilities, and automation integration in alignment with industry standards (ASME BPE, ISO, DIN, GAMP5).
• Collaborate with cross-functional leaders in Manufacturing, QA/QC, R&D, Compliance, and Project Management.

Leadership & Strategy:

• Oversee and approve engineering deliverables including P&IDs, GA & layout drawings, BOMs, and project documentation aligned with URS.
• Review comprehensive project plans and cost estimates; track progress, risks, and performance metrics.
• Drive the timely delivery and quality of engineering solutions across all stages: design, FAT, SAT, commissioning, and handover.

Project Oversight & Delivery:

• Guide engineering team in mechanical design reviews, component selection, risk analysis (FMEA), and system integration for vessels, fermenters, bioreactors, CIP/SIP systems, etc.
• Maintain strong technical rigor in evaluating
• materials, processes, and technologies for new and existing product development.
• Ensure adherence to regulatory requirements (21 CFR Part 11, GAMP5) and customer expectations.

Technical Excellence:

• Promote adoption of new technologies, smart engineering tools (AutoCAD Inventor, Plant 3D, Solid Edge), and digital practices across teams.
• Drive product and process improvement through CAPA programs, data-driven design changes, and performance testing analytics.
• Lead cost optimization and value engineering initiatives.