Piyush Sonavane

Lead and manage validation activities for equipment used in a GMP biologics manufacturing facility, ensuring timely execution and compliance. Apply Quality by Design (QbD) principles during commissioning and qualification to ensure equipment is fit for intended use from the start. Investigate and resolve equipment-related issues quickly, minimizing impact on project timelines and production schedules. Collaborate closely with production, quality, and engineering teams to confirm equipment performance and readiness for operations. Maintain accurate and organized documentation for equipment design, commissioning, and qualification activities. Ensure all commissioning and qualification packages meet industry standards, regulatory requirements, and GMP guidelines.

Executed and documented IQ/OQ/PQ protocols for equipment such as refrigerators, freezers, LN₂ cryo units, cold rooms, and incubators in alignment with cGMP and FDA guidelines. Coordinated commissioning and installation activities with Engineering, QA, and vendor teams to meet project quality and timeline goals. Conducted P&ID walkdowns and reviewed PFDs and design documentation to confirm system readiness and design intent. Applied risk-based approaches (FMEA, 5 Whys) and implemented CAPA actions to enhance system reliability and reduce deviations. Performed temperature mapping and calibration using Kaye Validators, data loggers, and reference standards for environmental qualification. Supported change control, deviation tracking, and data integrity assessments, ensuring complete traceability in project documentation. Developed tracking tools to streamline resource allocation and documentation workflows, reducing bottlenecks and improving project visibility.

Directed large-scale operational teams, overseeing staffing, performance, and daily coordination for 500+ personnel to ensure consistent service delivery and campus-wide coverage. Optimized operational workflows, streamlining procedures and communication channels to improve response times to security incidents by 30% and enhance overall efficiency. Monitored and enforced compliance with safety, security, and access-control protocols, maintaining a 95% adherence rate across all operational units. Led real-time incident management, coordinating with dispatch, field staff, and public safety teams to ensure timely, accurate, and safe resolution of on-campus events. Oversaw shift readiness and execution, including station assignments, timekeeping accuracy, documentation, and briefing/debriefing processes to maintain operational continuity. Provided coaching, performance feedback, and corrective action to frontline staff, fostering a culture of accountability, professionalism, and continuous improvement. Ensured cross-departmental coordination, collaborating with Residence Life, NUPD, Facilities, and other campus partners to support access control, emergency response, and service requests.

Actively monitor residence hall entrances and lobbies to maintain a secure environment. Utilize advanced access control systems to verify resident status, manage entry permissions, and accurately log guest activity. Provide exceptional customer service to residents, guests, and visitors, ensuring a welcoming and safe experience on campus. Execute detailed tasks with precision, following supervisor instructions while demonstrating independent problem-solving skills. Act as a liaison between residents, administrative offices, and various University resources to address concerns and facilitate communication. Collaborate effectively with Northeastern Police (NUPD), Residential Life, and other University staff to ensure coordinated security measures and response protocols

Delivered engineering and validation projects within defined scope, schedule, and cost under cGMP and 21 CFR Part 11 guidelines. Enhanced documentation accuracy and process tracking, increasing team efficiency by 20% and maintaining on-time completion across all assignments. Executed equipment qualification and maintenance validation for filling lines, HVAC, and utility systems, improving equipment readiness by 15% and operational performance by 20%. Deployed a Computerized Maintenance Management System (CMMS), reducing maintenance backlog by 40% and improving uptime by 25%. Coordinated change control, deviation logs, and qualification records to maintain compliance and audit readiness. Reviewed submittals, managed RFI/transmittal logs, and aligned vendor documentation with project specifications. Shortened procurement cycles through Coupa, improving supplier coordination and material availability. Supervised critical utilities—water, steam, nitrogen—maintaining uninterrupted operations for production areas. Conducted FMEA-based risk reviews to identify potential failures, reducing operational hazards by 50% and improving system reliability by 30%. Documented project activities, revisions, and approvals, improving traceability and reporting accuracy by 45%. Organized weekly progress reviews with QA, engineering, and production teams to address risks and maintain alignment.

Performed calibration and qualification of laboratory and production instruments in accordance with design and quality specifications. Developed and implemented preventive calibration plans, improving equipment uptime by 25% and reducing errors by 50%. Maintained 99% instrument accuracy through adherence to strict calibration and documentation standards. Verified technical drawings and equipment layouts to ensure compliance with engineering and safety requirements. Supported CAPA investigations and audit readiness by maintaining traceable calibration records and managing deviations. Enforced safety and procedural protocols, maintaining a 100% safety record across all calibration activities.

Acquired expertise in design principles and practical engineering for aircraft structures, prioritizing performance and safety enhancements. Completed stress analysis training on structural components, enhancing load distribution and failure mode understanding through simulation. Conducted material and structural testing, including strain gauging, aligning analytical predictions with actual results to refine designs. Excelled in engineering drawing, producing detailed 2D drafts and 3D models for aircraft components, streamlining communication and manufacturing. Investigated fatigue and fracture mechanics in materials, driving the development of more durable aircraft structures through thorough analysis. Optimized aerodynamics of structures through advanced computational fluid dynamics simulations, solving complex engineering challenges. Innovated with aerospace materials and manufacturing technologies, such as composites and additive manufacturing, to create efficient structures. Applied skills to meet technical specifications and deadlines, coordinating resources and teams. Implemented quality assurance protocols, ensuring designs and processes surpassed industry standards for safety and quality. Committed to continuous learning, staying updated on aerospace trends and technologies to introduce innovative solutions in engineering projects.