David Rodríguez

Senior Engineering Manager with 20+ years of experience in pharmaceutical and high-tech manufacturing environments. Proven expertise leading engineering and maintenance teams, improving equipment reliability, and ensuring compliance with FDA, GMP, and ISO standards. Strong background in utilities, equipment lifecycle management, validation (IQ/OQ/PQ), and continuous improvement initiatives.

Demonstrated ability to optimize operations, reduce downtime, and lead cross-functional teams in complex, regulated environments. Bilingual (English/Spanish). Proficient in project management, maintenance systems, and technical problem-solving.

Project Control – Capital Projects - LUMA Energy - Santurce, PR

(2024-01 - 2024-10)

• Managed project planning, scheduling, and execution to ensure on-time delivery of capital projects.
• Monitored and controlled project budgets, aligning costs with financial targets.
• Identified risks and implemented mitigation strategies to prevent delays and cost overruns.
• Prepared and delivered project status reports, maintaining accurate documentation and stakeholder communication.

Engineering Manager - AMGEN Manufacturing Limited - Juncos, PR

(2003 - 2022)

Engineering Manager – AML 14 - AMGEN Manufacturing Limited - Juncos, PR

(2011 - 2022)

• Led startup and commissioning of plant and clean utilities systems in compliance with regulatory requirements.
• Supervised maintenance operations, improving equipment reliability and uptime.
• Developed SOPs and preventive maintenance programs aligned with GMP and quality standards.
• Managed a team of 22 employees including technicians, engineers, and supervisors.
• Supported validation activities (IQ/OQ/PQ) and ensured readiness for regulatory inspections.

Engineering Manager – AML 4 - AMGEN Manufacturing Limited - Juncos, PR

(2003 - 2008)

• Directed maintenance of plant and clean utility systems to ensure operational continuity.
• Provided engineering support during equipment startup and validation processes.
• Executed factory acceptance tests (FAT) and supported equipment commissioning.
• Oversaw projects for QA labs and warehouse facilities.

Maintenance Engineer Supervisor - Lilly del Caribe - Carolina, PR

(2002 - 2003)

• Provided engineering support for startup and validation of manufacturing systems.
• Managed spare parts inventory to ensure equipment availability and maintenance efficiency.

Packaging Equipment Manager / Project Manager - Wyeth Pharmaceutical Company - Guayama, PR

(2001 - 2002)

• Developed functional specifications for packaging equipment.
• Executed equipment qualifications and supported quality investigations.

Senior Manufacturing Engineer Supervisor - Intel Puerto Rico Ltd - Las Piedras, PR

(1991 - 2001)

• Led equipment selection, installation, and maintenance strategies.
• Implemented SPC methodologies to improve process performance and product quality.

Master of Business Administration (MBA) - Management - Turabo University, PR

Bachelor of Science in Mechanical Engineering (BSME) - Mechanical Engineering - University of Puerto Rico, Mayagüez