Assistant Manager - Engineering Projects (Formulations)

Role & responsibilities

To plan, coordinate, and execute capital projects (CAPEX) involving OSD manufacturing equipment, HVAC systems, cleanroom infrastructure, and plant utilities. The role ensures all installations meet project timelines, budget constraints, and strict regulatory standards (GMP, WHO, USFDA, Schedule M) safely.

1. Project Planning & Execution

• Lead greenfield, brownfield, capacity expansion, and facility modification projects.
• Manage project schedules (using MS Project), monitor budgets, evaluate vendor bids, and mitigate risks.
• Review technical engineering documents including URS, layout drawings, P&IDs, equipment specs, and as-built drawings.

2. Mechanical, Process & HVAC Projects

• Oversee the layout review, installation, commissioning, and handover of core OSD equipment (Dispensing, Granulation, RMG, FBD, Compression, Coating, Capsule Filling, and Packing).
• Manage design, air balancing, HEPA integrity testing, and commissioning of HVAC systems for Grade C & Grade D cleanrooms.
• Direct projects for utility assets: AHUs, dehumidifiers, dust collectors, chillers, cooling towers, compressors, vacuum systems, purified water systems, and DG sets.

3. Qualification, Validation & Audit Support

• Coordinate FAT, SAT, IQ, OQ, and PQ activities alongside OEMs and internal validation teams.
• Ensure all engineering systems remain continuously audit-ready.
• Represent HVAC and mechanical engineering operations during regulatory and customer audits.

4. Utility, Energy & Safety Management

• Oversee operations of key utility infrastructure (Boilers, ETP, STP, Chillers) and drive energy conservation initiatives.
• Enforce rigorous EHS compliance at project sites, managing contractor safety permits (LOTO, hot work, work-at-height, confined spaces).
• Actively track QMS records, spearheading investigations for deviations and executing robust CAPAs.

Preferred candidate profile

• Education: B.E. / B.Tech in Mechanical Engineering.
• Total Experience: 10 to 15 years in Pharma engineering.
• Lead Experience: 4 to 5 years leading mechanical & HVAC projects.
• Industry Background: Pharmaceutical OSD (Solids & Semi-Solids) only.
• Job Location: Pithampur.
• Core Expertise: Grade C & D cleanroom HVAC systems (AHUs, Chillers, Air Balancing).
• Equipment Knowledge: Installation & testing of OSD machines (Granulation, Compression, Coating, Packing).
• Software Skills: AutoCAD and MS Project.
• Regulatory Compliance: USFDA, WHO, and cGMP standards.
• Documentation: Hands-on with FAT/SAT, IQ/OQ/PQ, Change Controls, and CAPAs.