AGM / DGM – Pharma Facility & Project Management – Pharma Solutions

Experience: 12–18 Years
Qualification: B.E./B.Tech – Chemical / Mechanical / Industrial Engineering / Biotechnology or B.Pharm / M.Pharm
Preferred: Experience in OSD, oncology, or high-potent pharmaceutical manufacturing

Role Summary

Lead pharmaceutical facility engineering and capital projects for high-potent oral solid dosage (OSD) manufacturing facilities. Manage facility design, equipment selection, project execution, qualification, commissioning, and stakeholder coordination while ensuring compliance with USFDA and EU GMP standards.

Key Responsibilities

• Lead facility design, layout planning, process flows, containment strategy, HVAC, and cleanroom requirements.
• Prepare URS and support selection of process, packaging, utility, and containment equipment.
• Manage project schedules, budgets, risks, consultants, OEMs, and cross-functional teams.
• Coordinate equipment installation, FAT, SAT, commissioning, and qualification activities.
• Support DQ, IQ, OQ, PQ, validation, and manufacturing readiness.
• Ensure compliance with GMP, USFDA, EU GMP, and high-potent containment requirements.
• Lead technical discussions with clients, engineering consultants, EPC partners, and equipment suppliers.
• Support international projects, including travel to the United States, during design, installation, qualification, and commissioning.

Required Skills

• Pharmaceutical Facility & Project Management
• OSD / High-Potent Manufacturing
• Facility Design & Layout Planning
• Equipment Selection & Qualification
• HVAC & Cleanroom Systems
• Commissioning & Validation
• GMP / USFDA / EU GMP Compliance
• HAZOP & Risk Assessment
• Stakeholder & Project Management
• Strong Technical & Leadership Skills

Mandatory: Experience in Oral Solid Dosage (OSD) manufacturing facilities. Experience in oncology or high-potent pharmaceutical manufacturing is highly preferred.