Assistant Manager - Engineering Projects (Formulations)

Rubicon Research; Pithampur; On-site; INR 4,500,000 - 6,500,000; Full time

Job summary

Rubicon Research in Pithampur, India, seeks a seasoned Mechanical & HVAC project leader to plan and execute CAPEX for OSD manufacturing, HVAC systems, and cleanroom infrastructure. You will drive regulatory compliance with GMP, USFDA, WHO standards while coordinating complex vendor bids and audits.

Ideal candidate has 10–15 years in pharma engineering, with 4–5 years leading mechanical and HVAC projects, and hands-on experience with OSD equipment.

Qualifications

• B.E./B.Tech in Mechanical Engineering.
• Total Experience: 10–15 years in Pharma engineering.
• Lead Experience: 4–5 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: FAT/SAT, IQ/OQ/PQ, Change Controls, and CAPAs.

Responsibilities

• Plan, coordinate, and execute CAPEX projects for OSD manufacturing equipment, HVAC, cleanroom infra, and utilities.
• Ensure installations meet timelines, budgets, and regulatory standards (GMP, WHO, USFDA, Schedule M).
• Lead greenfield, brownfield, capacity expansion, and facility modification projects.
• Manage project schedules (MS Project), budgets, bids, and risk mitigation.
• Review URS, layout drawings, P&IDs, equipment specs, and as-built drawings.
• Oversee layout review, installation, commissioning, and handover of core OSD equipment.
• Manage HVAC design, air balancing, HEPA testing, and commissioning for Grade C&D cleanrooms.
• Coordinate FAT, SAT, IQ, OQ, PQ activities with OEMs and validation teams.
• Ensure audit readiness and support regulatory audits.

Skills

Project planning

Regulatory compliance

Vendor management

Education

B.E./B.Tech Mechanical Engineering

Tools

AutoCAD

MS Project

Job description

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.