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.
2. 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.
3. 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.
4. 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.
5. 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
o Experience in EPCM environments or capital projects in Pharma industries
o Experience in Green field projects &Brownfield Projects
o Project Planning (MS Project or Primavera)
o Familiar in Piping & Package 3D Integration(Revits, CAD works or Navis work)
o Engineering Documentation
o FAT/SAT Management
o Cross-Functional Leadership
o Vendor Management
o Risk & Cost Control