Job Description Experience
n • 12–18 years of manufacturing operations experience within Medical Devices, Pharmaceuticals, Biologics, or regulated healthcare manufacturing.
n • Significant experience leading assembly and packaging operations.
n • Proven experience managing high-performing manufacturing teams in a cGMP-regulated environment.
n • Demonstrated success in regulatory inspections and quality systems.
n • Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement.
n Education
n • Bachelor's degree in engineering.
n • Master's degree preferred.
n Key Responsibilities
n Manufacturing Operations Leadership
n • Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and efficient manufacturing.
n • Own daily manufacturing performance with complete accountability for delivery commitments, quality, productivity, and cost.
n • Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity.
n • Ensure quarterly business deliverables and operational KPIs are consistently achieved.
n Delivery Excellence & Operational Ownership
n • Take complete ownership for manufacturing schedules and customer delivery commitments.
n • Establish and monitor operational KPIs including:
n o On-Time Delivery
n o Schedule Adherence
n o Overall Equipment Effectiveness (OEE)
n o Productivity
n o First Pass Yield
n o Right First Time
n o Packaging Efficiency
n o Training Compliance
n o Quality Metrics




n • Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply.
n Quality, Compliance & GMP Leadership
n • Champion a strong quality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements.
n • Ensure all manufacturing documentation is accurate, complete, and inspection-ready.
n • Maintain continuous audit preparedness for internal, customer, and global regulatory inspections.
n • Ensure compliance with applicable medical device quality standards and regulatory expectations.
n • Promote "Quality First" and "Right First Time" manufacturing practices across the organization.
n Process Excellence & Continuous Improvement
n • Drive continuous improvement initiatives focused on:
n o Defect reduction
n o Cycle time improvement
n o Cost optimization
n o Productivity enhancement
n o Waste elimination
n o Process standardization
n • Conduct process capability analysis for development and commercial products.
n • Recommend and implement improvements in manufacturing processes, equipment, layouts, and workflows.
n • Lead verification and validation activities for process changes where applicable.
n Cross Functional Collaboration
n • Work closely with:
n o Engineering & Maintenance
n o Quality Assurance
n o Quality Control
n o Supply Chain
n o Warehouse
n o Validation
n o Regulatory Affairs
n o Manufacturing Science & Technology (MSAT)
n • Ensure timely closure of cross-functional actions impacting manufacturing performance.
n • Support product transfers, process improvements, equipment qualification, and current product introductions.

📌 Medical Device & Packing Operations (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru