Project Management Manager

Project Manager – Process Packages (Drug Substance)

Responsible for managing the design, procurement, installation, commissioning, and qualification of pharmaceutical process packages related to drug substance (API/Biotech) facilities. Ensures project execution aligns with GMP standards, budget, schedule, and quality expectations while coordinating with internal teams, vendors, and stakeholders.

Key Responsibilities:

1. Project Planning & Execution

• Develop and manage project execution plans for drug substance process packages (e.g., upstream/downstream, CIP/SIP, buffer prep, chromatography skids).
• Define project scope, timelines, milestones, and deliverables.
• Lead project reviews, risk assessments, and progress tracking.

1. Design & Technical Coordination

• Review and approve PFDs, P&IDs, layouts, and datasheets for package systems.
• Coordinate with process, mechanical, piping, electrical, automation, and validation teams.
• Ensure design compliance with GMP, GEP, and global engineering standards.

1. Vendor & Procurement Management

• Prepare technical specifications, RFQs, and evaluate vendor bids.
• Manage supplier design, FAT/SAT, and package integration to site utilities.
• Control project budgets, contracts, and change management.

1. Construction & Commissioning

• Oversee installation, commissioning, and qualification (IQ/OQ) of drug substance packages.
• Interface with CQV, operations, and QA for system handover.
• Ensure safe execution of site activities as per EHS requirements.

1. Stakeholder Management & Reporting

• Serve as primary point of contact between engineering, procurement, QA, validation, and operations.
• Present regular project updates to management and cross-functional stakeholders.
• Drive issue resolution and maintain strong vendor relationships.

Qualifications:

• Master’s degree in mechanical or Industrial Engineering
• Minimum 8–10 years of experience in pharma/biotech project execution orengineering.
• Strong understanding of GMP, validation, and pharma regulatory requirements.
• Proficient in project management tools (MS Project, Primavera) andengineering software.
• Excellent communication, coordination, and stakeholder management skills.

Skills and Tools

• Experience in EPCM environments or capital projects in Pharma industries
• Experience in Green field projects &Brownfield Projects
• Project Planning (MS Project or Primavera)
• Familiar in Piping & Package 3D Integration(Revits, CAD works or Navis work)
• Engineering Documentation
• FAT/SAT Management
• Cross-Functional Leadership
• Vendor Management
• Risk & Cost Control