Senior Validation Engineer

Amneal India • Brookhaven, NY

21h

About The Position

The Senior Validation Engineer is responsible for leading the installation, upgrade, and integration of manufacturing and packaging equipment within the sterile facility, ensuring all systems meet design specifications and operational requirements. This role will oversee and execute qualification activities, including FAT, SAT, IQ, OQ, and PQ while managing project timelines, budgets, and resources to ensure successful and timely completion of engineering initiatives.

Responsibilities

• Lead manufacturing and packaging equipment installation/upgrades projects for sterile operations. Develop project scopes, technical plans, feasibility analysis, risk assessments, budgets, and execute aligned with business requirements. Coordinate activities related to procurement and contract management and manage maintenance activities by executing and tracking in accordance with organization SOPs.
• Lead qualification activities, including factory acceptance test (FAT), site acceptance test (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for manufacturing and packaging equipment. Support to develop validation master plan, requalification strategy and environmental monitoring performance qualification (EMPQ). Manage requalification activities per schedule and requirements. Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements.
• Oversee and maintain manufacturing and packaging equipment to ensure optimal performance and efficiency. Lead the development of training materials to support maintenance training program and improvizes the facility maintenance program to optimize its costs, compliance and effectiveness.
• Execute new and revised SOPs, ensuring accuracy, compliance, and timely implementation. Lead change control processes and perform thorough impact assessments to evaluate operational, regulatory, and quality implications. Support investigations by identifying root causes, conducting data analysis, and driving effective CAPA implementation to prevent recurrence and enhance system performance.
• Monitor facility operations to ensure full compliance with all applicable local regulatory requirements, including those enforced by the fire department, building department, and public health authorities. Proactively identify compliance risks and ensure corrective actions are implemented to maintain a safe and compliant operating environment.
• Maintain engineering documents such as layouts, spare/parts materials, design for maintainability. Verify and develop P&ID, engineering layout, engineering drawings and engineering documents. Assists activities for qualification of the facilities and utilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed