Bikalpa Bastola

 Led manufacturing engineering initiatives to meet production goals and customer requirements.
 Drove yield improvement projects resulting in a 5% increase in product yield and improved process consistency.
 Led process improvement initiatives that increased OEE from 70 % to 80% (+10 points) through equipment and workflow optimization.
 Implemented Lean and Kaizen initiatives that improved productivity by 10% and cycle time reduction by 12%.
 Supported CAPA investigation together with quality team to reduce the production issues by 30%.
 Accurately executed manufacturing protocols with minimal supervision while maintaining adherence to quality and regulatory standards.
 Investigated nonconforming products and materials, performed root cause analysis and implemented corrective and preventive actions (CAPA) to ensure compliance with quality standards.
 Planed and lead internal audit activities within assigned scope; represented the site during external audits and drove corrective actions plan for findings.
 Actively supported daily manufacturing operations through participation in Lean Management systems, providing technical guidance for maintenance activities and capital improvement projects.
 Collaborated cross-functionally with production, quality, engineering, and maintenance team to drive operational excellence and continuous process improvement projects.
 Monitored key manufacturing performance indicators and implemented data-driven improvements to enhance product quality, throughput and operational reliability.

Performed cGMP manufacturing operations on compliance with batch records and SOPs.
 Led manufacturing engineering initiatives to meet production goals and customer requirements.
 Drove yield improvement projects resulting in a 5% increase in product yield and improved process consistency.
 Led process improvement initiatives that increased OEE from 70 % to 80% (+10 points) through equipment and workflow optimization.
 Implemented Lean and Kaizen initiatives that improved productivity by 10% and cycle time reduction by 12%.
 Supported CAPA investigation together with quality team to reduce the production issues by 30%.
 Accurately executed manufacturing protocols with minimal supervision while maintaining adherence to quality and regulatory standards.
 Investigated nonconforming products and materials, performed root cause analysis and implemented corrective and preventive actions (CAPA) to ensure compliance with quality standards.
 Planed and lead internal audit activities within assigned scope; represented the site during external audits and drove corrective actions plan for findings.
 Actively supported daily manufacturing operations through participation in Lean Management systems, providing technical guidance for maintenance activities and capital improvement projects.
 Collaborated cross-functionally with production, quality, engineering, and maintenance team to drive operational excellence and continuous process improvement projects.
 Monitored key manufacturing performance indicators and implemented data-driven improvements to enhance product quality, throughput and operational reliability.

 Defined project scope, objectives, and deliverables. Managed project timelines, multimillion budgets and resources. Led assets implementation in the plant by preparing design review and approval.
 Led team for URS Development, NDAs, Vendor Management, Design and Design review, Quotation, capital equipment budget management, Business case, equipment procurement, FAT, SAT, managing project issues, Validation and qualification along with test results and handing equipment to NPI/NPD and Operation team.

 Performed cGMP manufacturing operations according to documented procedures and batch records.
 Provided engineering leadership to the assigned areas of the manufacturing to establish resources and meet business goals and customer needs.
 Developed, modified, applied and maintained the quality standards and protocol for processing materials into partially finished or finished material products.
 Implemented safety, productivity, yield improvements, through project leadership or kaizen events with ownership for key manufacturing processes and products.
 Proactively identified areas for opportunity and drive efficient results.
 Devised and implemented methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
 Executed manufacturing protocols accurately and with limited supervision.
 Designed and specified inspection and testing mechanisms and equipment; conducted quality assurance tests, and performed statistical analysis to assess the cost and determined the responsibility for products or materials that do not meet standards and specifications.
 Engaged and involved in daily operations, supports/ participates in lean management systems, and provides direction/ support of maintenance and capital improvement projects.

 Developed and maintained FMEAs, control plans, work instructions, SOPs, validation protocols, inspection plans and QMS documentation to support manufacturing processes, quality controls and regulatory compliance.
 Executed IQ/OQ/PQ, equipment qualification, equipment onboarding, in-process, and final inspections while supporting risk management, process validation, acceptance criteria, and quality plan requirements.
 Led nonconformance investigations, containment activities, root cause analysis (5-whys, Fishbones, FMEA), CAPA implementation, and effectiveness verification to improve product quality and manufacturing performance.
 Analyzed SPC, KPI, and process capability data using Minitab, driving continuous improvement initiatives and identifying systemic risks within manufacturing operations.
 Collaborated with Manufacturing, Engineering, and Quality teams to resolve quality issues, support audits, maintain document control, and ensure compliance with FDA, ISO 13485 and QMS requirements.

 Led equipment, utility and process validation activities while maintaining GMP-complaint documentation and SOPs.
 Drove manufacturing process improvements through Lean Six Sigma, CAPA and continuous improvement initiatives to enhance quality and efficiency.
 Developed and revised quality documentation, procedures, and validation protocols to ensure compliance with local regulatory internal standards.
 Collaborated with cross-functional teams to optimize manufacturing processes, implement process control, and improve product quality.

• Led process improvement initiatives, enhancing production efficiency and reducing waste in manufacturing operations.
• Developed and implemented data-driven strategies to optimize supply chain management and inventory control.
• Collaborated with cross-functional teams to design ergonomic workstations, improving employee comfort and productivity.
• Analyzed production workflows using Lean methodologies, identifying bottlenecks and implementing solutions to streamline processes.

• Led cross-functional teams to deliver projects on time and within budget.
• Developed project schedules using advanced project management software.
• Conducted risk assessments to identify potential project challenges and mitigate issues.
• Coordinated with stakeholders to ensure alignment on project objectives and deliverables.