AGM / DGM - Engineering & Projects (Injectable facility)

Role & responsibilities

• Lead engineering and CAPEX projects including greenfield, brownfield, expansion, and facility modification projects.
• Manage projects from concept/basic engineering to detailed engineering, procurement, installation, commissioning, and handover.
• Lead pharmaceutical facility, cleanroom, manufacturing area, and process equipment installation projects.
• Prepare/review URS, technical specifications, layouts, drawings, and vendor documents.
• Coordinate with consultants, EPC contractors, equipment vendors, QA, Validation, Production, EHS, Procurement, and other stakeholders.
• Manage FAT, SAT, Commissioning, DQ/IQ/OQ/PQ support, as applicable.
• Ensure projects are completed within approved scope, budget, timelines, GMP, quality, and safety requirements.
• Support regulatory/customer audits and ensure timely closure of project-related deviations, CAPA, and change controls.
• Lead and develop the Engineering & Projects team.
• Drive project cost optimization and effective CAPEX utilization.

Preferred candidate profile

• 1520+ years of experience in pharmaceutical engineering / projects, preferably in injectables/sterile manufacturing.
• Strong experience in CAPEX project execution, cleanrooms, facility projects, pharmaceutical equipment installation, and commissioning.
• Good understanding of GMP, US FDA/EU GMP/WHO GMP requirements.
• Strong project management, vendor management, negotiation, and team leadership skills.