Sr. Engineer - Maintenance Reliability
On-siteAibonito, Aibonito, Puerto Rico
Job Summary
Provide engineering support to manufacturing operations to ensure production schedules are achieved while meeting quality, compliance, and cost objectives. Lead and coordinate manufacturing automation projects, ensuring compliance with corporate engineering standards, regulatory requirements, and site objectives. Apply engineering principles and problem-solving methodologies to improve manufacturing processes, equipment performance, and product quality. Utilize engineering tools and techniques such as FMEA, Design of Experiments (DOE), Statistical Process Control (SPC), Process Modeling, and software development to resolve technical challenges. Develop, manage, and control capital budgets for manufacturing and automation projects. Lead small project teams, contractors, vendors, and cross-functional resources to successfully execute engineering initiatives. Monitor project timelines, budgets, and expenditures, providing regular updates and recommendations to leadership. Identify and implement process improvements that increase efficiency, reduce costs, improve reliability, and enhance product quality. Evaluate and recommend new manufacturing technologies, automation systems, equipment, materials, and processes. Provide technical leadership and supervision to engineers, technicians, technologists, maintenance personnel, mold makers, and related support functions. Coordinate preventive maintenance strategies for manufacturing and automation equipment, ensuring optimal performance and reliability. Review, improve, and maintain preventive maintenance plans, equipment documentation, and mold maintenance programs. Oversee mold maintenance activities, including repair, cleaning, refurbishment, spare parts management, and documentation control. Author, execute, review, and support Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and software validation activities. Develop and review User Requirement Specifications (URS) and other engineering documentation. Support manufacturing operations through continuous improvement projects, operational excellence initiatives, and strategic business projects. Ensure compliance with FDA Quality System Regulations, OSHA requirements, company policies, and all applicable regulatory standards. Promote a strong safety culture by driving Environmental, Health & Safety (EHS) initiatives and maintaining a zero-harm workplace. Protect confidential information and consistently adhere to data
Required Qualifications
- Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related engineering discipline
- Minimum of 3-5 years of experience in manufacturing engineering, automation, maintenance engineering, project engineering, or a related industrial environment
- Strong knowledge of manufacturing processes, automation systems, equipment validation, and continuous improvement methodologies
- Experience developing and managing project budgets, capital expenditures, and resource planning
- Proficiency with engineering and business software applications, including Microsoft Office and project management tools
- Bilingual proficiency in English and Spanish with strong written and verbal communication skills
- Experience with PLCs, HMIs, SCADA systems, industrial automation, robotics, and manufacturing control systems
- Knowledge of FDA regulations, cGMP requirements, software validation, and computer system validation
- Experience with CAD software and engineering analysis tools
- Project Management certification (PMP) or equivalent project leadership experience
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