Designation: AGM / DGM
Experience: 12–18 Years

Job Overview

We are looking for an experienced AGM / DGM – Pharmaceutical Facility & Project Management to lead the design, execution, qualification, and commissioning of a high-potent oral solid dosage manufacturing facility for a global oncology pharmaceutical client.

The ideal candidate will have extensive experience in pharmaceutical facility engineering, capital projects, equipment qualification, and regulated manufacturing environments. This role serves as the technical bridge between engineering consultants, equipment suppliers, validation teams, client stakeholders, and internal project teams to ensure successful project delivery while maintaining compliance with USFDA and EU GMP standards.

Key Responsibilities

Facility Design & Engineering

• Coordinate with engineering consultants for pharmaceutical facility layout design and review.
• Define process flow, personnel flow, material flow, and waste flow requirements.
• Support containment strategy design for high-potent oral solid dosage manufacturing facilities.
• Review HVAC systems, cleanroom classifications, pressure cascades, and containment concepts.
• Participate in HAZOP studies, risk assessments, and engineering design reviews.

Process Equipment & Technology Selection

• Prepare User Requirement Specifications (URS) for process, packaging, and utility equipment.
• Evaluate and recommend equipment suppliers for:
  • Dispensing
  • Granulation
  • Blending
  • Compression
  • Encapsulation
  • Coating
  • Packaging
  • Containment systems
• Coordinate technical discussions with OEMs and engineering consultants.
• Support FAT, SAT, installation, commissioning, and equipment qualification activities.

Project Management

• Develop project schedules and monitor key milestones.
• Coordinate activities across engineering, validation, quality, production, procurement, and external consultants.
• Identify project risks and implement mitigation strategies.
• Support project budgeting, cost monitoring, and execution planning.
• Ensure projects are delivered on time, within budget, and in compliance with quality standards.

Qualification & Validation

• Support Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Review qualification protocols and validation documentation.
• Ensure facility and equipment designs comply with USFDA, EU GMP, and containment requirements.
• Participate in commissioning and manufacturing readiness activities.

Client & Stakeholder Management

• Serve as the primary technical interface between the client and project teams.
• Participate in project review meetings, technical discussions, and progress updates.
• Support technology transfer and manufacturing readiness initiatives.
• Collaborate with engineering consultants, EPC partners, OEMs, and internal stakeholders throughout the project lifecycle.

International Project Support

• Provide on-site technical support during:
  • Facility Design & Engineering
  • Installation & Construction
  • Qualification & Validation
  • Commissioning & Start-up
• Travel internationally, particularly to the United States, for extended project assignments as required.
• Maintain eligibility for obtaining a US Business Visa (B1/B2 or equivalent).

Required Qualifications

Educational Qualification

• B.E. / B.Tech in:
  • Chemical Engineering
  • Mechanical Engineering
  • Industrial Engineering
  • Biotechnology
  • Equivalent discipline
• OR B.Pharm / M.Pharm
• Advanced qualification in Pharmaceutical Engineering or Project Management is preferred.

Experience Required

• 12–18 years of experience in:
  • Pharmaceutical facility engineering
  • Capital project management
  • Plant design
  • Technology transfer
  • Facility commissioning
• Mandatory experience in Oral Solid Dosage (OSD) manufacturing facilities.
• Experience in oncology or high-potent pharmaceutical manufacturing is highly preferred.
• Exposure to pharmaceutical engineering consultancies, EPC firms, or regulated pharmaceutical manufacturing environments is desirable.

Required Skills

• Pharmaceutical Facility Engineering
• Capital Project Management
• Facility Design & Layout Planning
• High-Potent Containment Systems
• Equipment Selection & Qualification
• HVAC & Cleanroom Design
• Commissioning & Validation
• GMP, USFDA & EU GMP Compliance
• Risk Assessment & HAZOP
• Cross-Functional Stakeholder Management

Why Join Us?

• Lead high-impact pharmaceutical facility projects for global oncology manufacturing.
• Work with international clients on advanced pharmaceutical engineering initiatives.
• Gain exposure to cutting-edge pharmaceutical technologies and global compliance standards.
• Excellent career progression in pharmaceutical engineering and project leadership.