Manager

To plan, coordinate, execute, and manage API (Active Pharmaceutical Ingredient) manufacturing projects, including new plant setup, capacity expansion, technology upgrades, process improvements, and regulatory compliance, ensuring timely completion within approved budgets and quality standards.

2. Key Responsibilities
A. Project Planning & Execution

Plan and execute new API manufacturing plant projects and expansion projects.

Prepare project schedules, budgets, resource plans, and execution strategies.

Coordinate civil, structural, mechanical, electrical, instrumentation, and utility activities.

Monitor project progress against milestones and ensure timely completion.

Manage contractors, consultants, vendors, and engineering agencies.

B. Technical & Engineering Coordination

Coordinate design and engineering of API manufacturing facilities.

Review PFDs, P&IDs, equipment layouts, equipment specifications, and utility requirements.

Ensure proper design of reactors, centrifuges, dryers, filters, storage tanks, and associated equipment.

Coordinate HVAC, purified water, steam, chilled water, cooling towers, nitrogen, and other utility systems.

Ensure compliance with GMP and applicable safety standards.

C. Regulatory & Quality Compliance

Ensure projects comply with:

Schedule M requirements, as applicable.

WHO-GMP requirements.

USFDA and EU-GMP requirements, where applicable.

Environmental and pollution control regulations.

Factory safety and statutory requirements.

Coordinate with QA, QC, EHS, Production, and Engineering departments.

Ensure proper documentation, qualification, and validation support.

D. Budget & Cost Control

Prepare and monitor project CAPEX budgets.

Control project expenditure and identify cost-saving opportunities.

Review vendor quotations and technical-commercial proposals.

Monitor purchase orders, contracts, and payment milestones.

E. Commissioning & Handover

Coordinate equipment installation and commissioning.

Ensure completion of FAT, SAT, IQ, OQ, and other applicable qualification activities.

Coordinate trial runs and performance verification.

Ensure smooth handover of completed projects to the operations team.

F. Team & Stakeholder Management

Lead project engineers and cross-functional teams.

Conduct regular project review meetings.

Prepare MIS reports and project progress dashboards.

Escalate project risks, delays, and technical issues to management.

3. Educational Qualification
B.E./B.Tech in Chemical, Mechanical, Electrical, or Instrumentation Engineering.

M.Tech/MBA in Project Management would be an added advantage.

4. Experience
10–15 years of experience in pharmaceutical/API project execution.

Minimum 5 years in project management or project leadership.

Experience in greenfield and brownfield API manufacturing projects.

Experience in CAPEX management, engineering coordination, and plant commissioning.