Summary

To provide strategic leadership for the design, execution, and maintenance of world-class pharmaceutical infrastructure. This dual-focus role ensures maximum uptime for existing API and FDF production lines while leading greenfield and brownfield expansion projects to meet global regulatory standards (US-FDA, EMA, WHO-GMP). This is a full-time position with a mandatory 6-day work week.

Key Responsibilities

Infrastructure Project Management (Greenfield & Brownfield)

• End-to-End Project Execution: Lead the planning, design, and commissioning of new API and FDF facilities.
• Design & Engineering: Oversee architectural plans, HVAC design, heat load calculations, utility requirements etc using tools like AutoCAD and SolidWorks for Pharmaceutical API & formulation plant and formulation unit.
• Vendor & Stakeholder Management: Select and supervise construction management firms, specialized pharmaceutical equipment vendors, and civil contractors.

Facilities & Utility Operations

• Reliability & Maintenance: Implement predictive and preventive maintenance programs for high-uptime utility equipment, including chillers, electrical panels, DGs, and exhaust systems. Knowledge in automation & latest technologies of machineries.
• Specialized API/FDF Systems: Manage critical infrastructure specific to APIs (solvent handling, chemical reactors, purification) and FDF (sterile processing, cleanrooms, cold chain).
• Energy & Sustainability: Drive sustainability initiatives, including alternative energy integration, water reduction, and carbon footprint optimization.

Regulatory & Safety Compliance

• GMP Compliance: Ensure all facilities adhere to ICH Q7 (for APIs) and relevant global guidelines for non-sterile dosage forms. In-depth knowledge for facility compliance requirement for highly reputed markets.
• Validation & Commissioning: Lead cross-functional teams through DQ, IQ, OQ, and PQ phases for new infrastructure and equipment.
• EHS Leadership: Maintain 100% compliance with environmental and safety standards (OSHA, ISO 14000) to ensure a safe workspace for all personnel.

Skills Required

• Technical Skills: Proficiency in AutoCAD, SAP, MS Project, and other project management software.
• Certifications: Certified Facilities Manager (CFM), PMP, or equivalent professional certification preferred.
• Negotiation Skills: Strong contract negotiation and commercial management capabilities.
• Vendor Selection: Proven experience in evaluating, selecting, and managing contractors, consultants, and equipment suppliers.
• International Exposure: Experience working with international pharmaceutical machinery manufacturers and global technology partners.