Site Engineering Head (Sterile/Injectables)

Overview

Site Engineering Head focused on sterile/injectables manufacturing maintenance and reliability, ensuring equipment functionality, calibration compliance, and zero-downtime initiatives.

What you'll do

• Ensure manufacturing equipment operates within validated process parameters and meets calibration compliance requirements.
• Lead preventive and breakdown maintenance programs to drive reliability and equipment availability.
• Run continuous improvement initiatives including LDM, TPM, debottlenecking, and resource optimization.
• Prepare and execute CAPEX proposals and projects within timelines and compliance frameworks.
• Manage OPEX budgeting, tracking, monitoring, and KPI development for efficiency and cost control.
• Maintain GMP, safety standards, SOP compliance, audit readiness, and QMS activities such as documentation, CAPA closure, and training.

What you'll need

• Minimum 15+ years of experience.
• 8+ years in sterile engineering or plant maintenance roles.
• 5+ years as team lead managing mechanical/electrical/HVAC/instrumentation/operations/engineering projects in pharma manufacturing (desired).
• Graduation in instrumentation, mechanical, electrical, engineering, or related field is mandatory.
• Lean methodologies, risk management, and Total Productive Maintenance.
• Knowledge of current Good Manufacturing Practices (cGMPs) and audit management.

Details

• Location: Duvvada, AP, India.