Project Manager – Mechanical

Aristo Pharmaceuticals Pvt. Ltd.; Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Aristo Pharmaceuticals Pvt. Ltd. in Mumbai seeks a seasoned Project Manager - Mechanical to lead end-to-end execution of pharmaceutical projects focused on mechanical systems, utilities and process equipment.

The role demands hands-on experience in greenfield/brownfield project execution within regulated pharma environments. You will coordinate with QA, Production, R&D and Regulatory, review technical specs, manage budgets, and ensure timely delivery with strict adherence to cGMP and global

Qualifications

• 15–20 years of experience in pharma industry (mechanical)
• Proven experience in greenfield pharmaceutical projects
• Hands-on expertise in mechanical systems, utilities and process equipment
• Knowledge of cGMP, USFDA, WHO, EU GMP guidelines

Responsibilities

• Lead greenfield pharmaceutical projects from concept to commissioning and qualification.
• Define project scope, timelines, milestones, and deliverables using MS Projects or Primavera.
• Ensure projects are delivered within budget, timeline, and quality standards.
• Coordinate with QA, Production, R&D, and Regulatory to align requirements.
• Review engineering designs and tender documents for mechanical systems and utilities.
• Monitor vendor performance, FAT/SAT activities, and timely delivery.
• Develop new vendors and manage cross-functional teams.

Skills

Project management

Pharma industry experience

Greenfield/brownfield execution

Regulatory awareness

Education

B.E. Mechanical / B. Tech Mechanical

Tools

MS Project

Primavera

AutoCAD

Job description

Qualification: B.E. Mechanical / B. Tech Mechanical

Experience: 15-20 years (Pharma Industry)

Mandatory: Proven experience in Greenfield pharmaceutical projects

Role Overview

The Project Manager - Mechanical will be responsible for end-to-end execution of pharmaceutical projects with a strong focus on mechanical systems, utilities, and process equipment. The role requires hands-on expertise in greenfield/brownfield project execution, particularly in regulated pharma environments.

Key Responsibilities

Project Execution & Management

• Lead greenfield pharmaceutical projects from concept to commissioning and qualification.
• Define project scope, timelines, milestones, and deliverables w.r.to MS projects, Primavera software's..
• Ensure projects are delivered within budget, timeline, and quality standards.
• Coordinate with cross-functional teams including QA, Production, R&D, and Regulatory.
• Review and finalize engineering designs, documents and designs received from technical consultant:
• Utility systems (WFI, pure steam, compressed air, vacuum, chilled water)
• Expertise in utility capacity and efficiency calculations.
• Process equipment (filling lines, sterilizers, isolators, etc.)
• Process equipment for formulation of Liquid orals, Tablets and Capsules.
• Expertise in Energy saving concepts.
• Ensure compliance with cGMP, USFDA, WHO, EU GMP guidelines.
• Prepare URS
• Review of Technical specifications and tender documents.
• Evaluate technical bids and conduct technical discussions.
• Monitor vendor performance, FAT/SAT activities, and timely delivery.
• Development of new venders.

Budgeting & Cost Control

• Prepare and manage project budgets.
• Track expenditures and implement cost-control measures.
• Ensure optimum utilization of resources.

Risk & Safety Management

• Identify project risks and implement mitigation strategies.
• Ensure adherence to EHS and safety standards at project sites.
• Strong knowledge of pharmaceutical facility design (OSD & parenteral)
• Expertise in greenfield project execution
• Technical knowledge of mechanical systems & utilities in pharma
• Project planning and scheduling tools (MS Project or equivalent)
• Expertise in AutoCAD 2 D and 3 D software's.
• Co-ordination with technical /engineering consultant, site team and vendors for resolving technical problems and also timely project execution
• Excellent cross-functional coordination and leadership abilities
• Understanding of GMP and regulatory requirements.