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 strong 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 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.

📌 Mechanical Design Manager (Pune)
🏢 Drishti Consultants
📍 Pune