Role & responsibilities:

Leadership & Strategy:
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.

Project Oversight & Delivery:
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.

Technical Excellence:
Guide engineering team in mechanical design reviews,



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

Innovation & Continuous Improvement:
Promote adoption of recent 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.

📌 Mechanical Design Manager Pune
🏢 Drishti Consultants
📍 Pune