Associate General Manager Engineering (API Projects)

Role & responsibilities

1. Project Planning & Execution

• Lead

  end-to-end project management

  for new API manufacturing facilities, plant expansions, and capacity enhancement projects.
• Develop and manage

  project schedules, budgets, timelines, and resource plans

  using tools such as

  Primavera or MS Project

  .
• Coordinate with

  consultants, architects, and EPC contractors

  for basic and detailed engineering, procurement, and construction activities.
• Drive

  installation, commissioning, and qualification (IQ/OQ/PQ)

  of process, utility, and ancillary systems.
• Ensure

  on-time delivery

  of projects within approved budgets and scope.

2. Engineering & Technical Oversight

• Review and approve

  Process Flow Diagrams (PFDs)

  ,

  Piping & Instrumentation Diagrams (P&IDs)

  , equipment data sheets, and layout drawings.
• Ensure engineering design adheres to

  cGMP

  ,

  USFDA

  ,

  EMA

  ,

  MHRA

  , and

  WHO

  standards.
• Support

  technology transfer

  ,

  process scale-up

  , and

  equipment selection

  in coordination with R&D and Manufacturing teams.
• Provide

  technical leadership

  in areas such as

  utilities (WFI, clean steam, HVAC, chillers, compressed air)

  and

  cleanroom design

  .

3. Cross-Functional Coordination

• Collaborate closely with internal teams including

  Production, Quality Assurance, Quality Control, Regulatory Affairs, EHS, and Procurement

  for smooth execution.
• Work with

  Finance and Procurement

  for cost estimation, vendor selection, contract negotiation, and budget tracking.
• Lead

  site-based project teams

  , ensuring effective communication, accountability, and goal alignment.
• Build strong relationships with external partners, consultants, and suppliers to ensure best-in-class project delivery.

4. Compliance, Quality & Safety

• Ensure strict adherence to

  EHS (Environment, Health & Safety)

  and

  Quality Management

  standards throughout project execution.
• Conduct

  Hazard and Operability Studies (HAZOP)

  , risk assessments, and implement mitigation strategies.
• Ensure all activities comply with

  statutory, local, and international regulatory

  requirements.
• Support readiness for

  regulatory audits and inspections

  related to project and facility setup.

5. Reporting & Documentation

• Prepare

  comprehensive project reports

  , including progress updates, risk analysis, and deviation reports, for senior management.
• Maintain

  accurate documentation

  as per GMP and project management protocols.
• Track project performance against defined

  KPIs and milestones

  , recommending corrective actions as needed.
• Present updates in

  management review meetings

  and provide visibility into project health and financial status.

Experience:

• Minimum

  15+ years

  of experience in

  API or bulk drug project management

  , preferably with leading pharmaceutical companies.
• Proven experience in executing

  Greenfield and Brownfield projects

  from concept to commissioning.
• Exposure to

  multi-location projects

  (India and/or international sites).
• Strong understanding of

  GMP facility design

  ,

  process equipment

  ,

  utilities

  , and

  HVAC systems

  .
• Familiarity with

  international regulatory guidelines

  USFDA, EMA, MHRA, WHO.
• Proficiency in

  project management tools

  such as

  Primavera, MS Project

  , and

  AutoCAD

  .