Senior Project Engineer

Role Summary

Senior Project Engineer at ADMA Biologics, Boca Raton, FL. Provide engineering, project management, manufacturing and maintenance support to the GMP manufacturing site, troubleshooting and implementing engineering solutions for existing processes and equipment; lead capital engineering and process improvement projects and design, procure, and commission new process and utility equipment.

Responsibilities

• Managing mid-to-large sized engineering projects by planning and tracking activities of cross-functional teams and contractors, developing schedules and performance requirements, and managing scope, schedule, and cost.
• Developing and executing commissioning plans to ensure process and utility systems/equipment are fit for use.
• Developing and reviewing process flow diagrams and P&IDs for new or modified systems.
• Directing and/or assisting in the design and execution of capital projects.
• Supporting engineering development with load calculations of flow, heating/cooling capacity, pressures, etc.
• Preparing engineering evaluations, change control documentation, testing plans, and CAPAs with technical writing.
• Leading investigations of process systems/equipment to determine root causes and implementing corrective actions; using statistical tools to analyze data and improve procedures and maintenance.
• Developing efficient PM plans for key manufacturing and utilities equipment and providing troubleshooting expertise.
• Serving as technical liaison for OSHA, regulatory, and audits related to maintenance/facility aspects.
• Assisting in writing regulatory documents for FDA submissions as required.
• Creating capital expenditure requests and purchase requisitions for approvals prior to procurement.

Qualifications

• Minimum of 10 years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment.

Skills

• Ability to follow cGMPs and procedures with attention to detail
• Ability to read and understand blueprints
• Ability to interpret regulations and implement appropriate procedural changes
• Ability to work in a high-pressure, deadline-driven environment
• Strong communication and collaboration with operations management
• Advanced knowledge of Microsoft Office and project software
• Excellent problem-solving and analytical skills; ability to convey technical concepts to non-technical stakeholders

Education

• Not specified

Additional Requirements

• No explicit travel or physical demands specified in the provided content.