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