Job DescriptionExperience

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 inregulatory inspections and quality systems.

N- Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement.

NEducation

n- Bachelor's degree in engineering.

N- Master's degree preferred.

NKey Responsibilities

nManufacturing Operations Leadership

N- Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and efficient manufacturing.

N- Own daily manufacturingperformance 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.

NDelivery Excellence & Operational Ownership

N- Take complete ownershipfor manufacturing schedules and customer delivery commitments.

N- Establish and monitor operational KPIs including:

No On-Time Delivery

no Schedule Adherence

No Overall Equipment Effectiveness (OEE)

No Productivity

no First Pass Yield

No Right First Time

no Packaging Efficiency

No Training Compliance

no Quality Metrics





N- Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply.

NQuality, Compliance & GMPLeadership

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.

NProcess Excellence & Continuous Improvement

N- Drive continuous improvement initiatives focused on:

No Defect reduction

no Cycle time improvement

No Cost optimization

no Productivity enhancement

No Waste elimination

no Process standardization

N- Conduct process capability analysis for development and commercial products.

N- Recommend and implementimprovements in manufacturing processes, equipment, layouts, and workflows.

N- Lead verification and validation activities for process changes where applicable.

NCross Functional Collaboration

N- Work closely with:

No Engineering & Maintenance

No Quality Assurance

no Quality Control

No Supply Chain

no Warehouse

No Validation

no Regulatory Affairs

No 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