Facilities Engineer II
MedTechPharmaRegulatory AffairsQuality Assuranceheoremafdacroraveinform
Job description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Facilities Engineer II Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. About Abbott Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Manufacturing Facilities Engineer II is within our Infectious Disease Developed Markets Business Unit located in Scarborough, Maine . This role will be responsible for maintaining assigned facilities systems, creating and implementing approved changes, and executing mid- scale projects. Working with engineering, technicians and production staff, this role troubleshoots and improves process and facilities related issues. Working with engineering, technicians and production staff, this role troubleshoots and improves process and facilities related issues with limited supervision, exercising sound engineering judgment in a regulated manufacturing environment. What You'll Do Responsible for ensuring compliance with local, state, and federal agencies. Manages and completes QMS (Quality Management System) actions and items related to facility processes and equipment as needed. Adheres and enforces all relevant safety protocols and philosophies for internal staff members and the actions of vendors working on relevant projects. Works closely with other departments to define, coordinate, and execute project actions to meet established timelines. Owns one or more critical facilities systems, ensuring performance, compliance, and reliability across their lifecycle. Leads structured root cause investigations for complex or recurring equipment and system failures, driving corrective and preventive actions. Develops, reviews, and maintains facilities system standards, specifications, SOPs, and design documentation. Reviews drawings, calculations, validation documentation, and change impacts to ensure technical accuracy and regulatory compliance. Serves as the primary technical interface with vendors and contractors for assigned systems, including scope definition and technical decision-making. Leads execution of medium-scale facilities projects and system upgrades, coordinating with engineering, technicians, quality, and operations. Supports and leads commissioning and validation activities, including test strategy development and data analysis. Evaluates existing systems for process suitability, capacity, and risk; develops improvement plans as needed. Manages and supports change control activities through Agile PLM or equivalent systems. Provides technical guidance and informal mentorship to Facilities Engineers I and Facilities Technicians. Participates in audits and inspections as a system subject matter expert. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Carries out duties in compliance with established business policies and procedures. Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job. Support department by performing related tasks as requested. Required Qualifications Bachelor's degree (BS) in Engineering or equivalent combination of education and experience. 3+ years of engineering experience in a manufacturing environment. Working knowledge of engineering principles, methodologies, and industry standards. Demonstrated ability to independently troubleshoot complex equipment and system issues. Experience reviewing technical documentation such as drawings, specifications, calculations and change records. Proficient in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, etc.) PREFERRED QUALIFICATIONS: · Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations. Experience working in Medical Device Manufacturing or a related regulated industry. Strong working knowledge of HVAC systems and/or manufacturing utilities. Experience supporting capital projects or major systems upgrades. Core Competencies Professionalism: Demonstrates integrity, accountability, respect, and commitment while representing Abbott’s values and supporting organizational goals. Technical Execution: Applies engineering principles to solve complex technical challenges independently with minimal supervision. Self-Motivation: Takes initiative, drives results, seeks continuous learning opportunities, and maintains a high level of productivity. Customer Focus: Effectively supports internal and external customers while balancing business needs, service expectations, and operational requirements. Technical Competencies Electrical & Mechanical Aptitude: Understands, diagnoses, and works effectively with electrical and mechanical systems and equipment. Facilities System Ownership: Maintains responsibility for system performance, reliability, compliance, and continuous improvement of facilities-related systems. CAD Proficiency: Utilizes computer-aided design (CAD) and related engineering software to develop, modify, an
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