Sr. Engineer - Maintenance Reliability

In this role, you will serve as a technical leader responsible for improving equipment uptime, optimizing preventive and predictive maintenance programs, and supporting critical manufacturing systems. You will partner with cross-functional stakeholders to implement reliability-centered maintenance strategies, execute capital and automation projects, and ensure compliance with regulatory and quality requirements. You will lead and mentor engineers, technicians, and maintenance personnel while fostering a culture of operational excellence, safety, and continuous improvement.

What You'll Be Doing

• 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 privacy and information security requirements.

What You'll Bring

• 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.