Title:  Senior Executive -Engineering Projects

Job Purpose

To plan, execute, and deliver engineering projects in a USFDA‑approved OSD manufacturing facility, ensuring compliance with GMP, USFDA, safety, quality, cost, and timelines, while supporting capacity expansion, new product introduction, technology upgrades, and regulatory readiness.

Key Responsibilities

1. Engineering Project Planning & Execution

• Lead capital and revenue engineering projects including new facilities, capacity expansion, equipment installation, process modification, and utilities enhancement.
• Prepare project scope, URS, feasibility studies, layouts, BOQs, timelines, and budgets.
• Coordinate end‑to‑end project execution from concept design to commissioning and handover.
• Monitor project milestones, cost control, vendor performance, and risk mitigation.

2. Equipment & Facility Projects (OSD Focus)

• Execution of projects related to:
  • Granulation, Compression, Coating, Blending, and Packing equipment
  • Material handling systems
  • Cleanroom modifications and HVAC upgrades
• Ensure equipment selection, layout optimization, FAT/SAT, installation, and commissioning meet GMP and operational requirements.
• Manage relocation and retrofit projects with minimal production disruption.

3. Utilities & Infrastructure Projects

• Handle engineering projects for HVAC, purified water, compressed air, nitrogen, electrical systems, and automation.
• Ensure compliance with energy efficiency, safety, and regulatory norms.
• Coordinate with external consultants for civil, electrical, and mechanical engineering works.

4. Compliance, Validation & Documentation

• Ensure all projects comply with USFDA, cGMP, EHS, and internal quality systems.
• Support DQ, IQ, OQ, PQ activities in coordination with QA and Validation teams.
• Prepare and review project documentation:
  • URS, FS, DS
  • Layouts, P&IDs
  • Qualification protocols and reports
  • Change controls, deviations, and risk assessments
• Participate in USFDA, regulatory, and customer audits related to engineering projects.

5. Cross‑Functional Coordination

• Work closely with Production, Quality Assurance, Quality Control, Validation, EHS, Procurement, and Finance teams.
• Support New Product Introduction (NPI) from an engineering readiness perspective.
• Coordinate plant shutdown activities for project execution.

6. Vendor & Contractor Management

• Finalize vendors and contractors for equipment, construction, and utilities.
• Manage technical evaluations, negotiations, and contractual deliverables.
• Ensure compliance of contractors with GMP, safety, and site policies.

7. Safety, Compliance & Best Practices

• Ensure safe execution of engineering projects with zero incidents.
• Implement EHS guidelines, permits, risk assessments, and safety audits.
• Drive adoption of best engineering practices, automation, and digitalization where applicable.

Key Performance Indicators (KPIs)

• On‑time and on‑budget project delivery
• Regulatory compliance with zero critical observations
• Successful commissioning and qualification
• Minimal production downtime due to projects
• Cost optimization and energy efficiency improvements

Educational Qualifications

• Bachelor’s degree in Engineering (Mechanical / Electrical / Instrumentation)

Experience Required

• 10–12 years of relevant experience in:
  • Engineering Projects in USFDA‑approved pharmaceutical OSD plants
  • Equipment installation, clean utilities, and GMP facility projects
• Proven experience in greenfield/brownfield pharma projects preferred

Required Skills & Competencies

• Strong knowledge of OSD manufacturing processes and equipment
• In‑depth understanding of cGMP, USFDA, and validation requirements
• Project management, stakeholder coordination, and documentation skills
• Vendor management and cost control expertise
• Proficiency in AutoCAD / project planning tools (MS Project / Primavera)
• Strong problem‑solving and execution mindset

Behavioral Competencies

• Ownership and accountability
• Attention to detail and compliance focus
• Ability to manage multiple projects simultaneously
• Strong communication and coordination skills