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 103,000 colleagues serve people in more than 160 countries.
MAIN PURPOSE OF ROLE
Support new custom equipment development projects for divisional product manufacturing. Primary role is to generate equipment life cycle documentation deliverables used for qualification of equipment for commercial manufacturing.
• Responsible for generating document deliverables in accordance with SOP4000 Equipment Controls procedures, including User Requirement Specifications, Risk Assessments, Design Specifications, Drawing and Bills of Material package, etc.
• Coordinate with various project stakeholders and team members to generate requirements and content, and to support delivering equipment that satisfies the needs for production level equipment and compliant with procedures and policies.
• Responsible for generation and execution of Design Acceptance Test and Equipment Qualification protocols.
• Generate and support approval of Change Orders required to release document deliverables in Document Control archives.
• Support Equipment group testing by maintaining test instruments and administrating the periodic calibration requirements.
• Ability to support multiple projects at various phases from Requirements Phase, to Design and Build phase, to Test and Qualification phase. Requires interfacing and assisting others within the Equipment group to move projects forward.
• Responsible for generation, approval, and closure of equipment work orders using our internal Maximo (CMMS system used to track reliability and maintenance records of manufacturing equipment).
• Coordinate with Vendors to ensure document deliverables from vendor are timely and in compliance with procedures.
• Travel to vendor sites for dry run and final Factory Acceptance testing of equipment.
• Coordination of crating and shipping of equipment or other project related shipping needs.
• Generate purchase requisitions using our XIAM requisition system.
• Assist with troubleshooting and repair of equipment.
• May provide work direction to other employees in work group.
• Plans and organizes project assignments of substantial variety and complexity.
• Initiates or maintains schedule for projects and project milestones.
• Establishes priorities of individual or project assignments.
• Solves complex problems requiring extensive interpretation of procedures and practices to provide leadership in evolving projects.
• Selects methods and practices to solve problems using ingenuity, creativity, and a high degree of independent action and initiative.
• Proposes solutions independently; makes decisions on projects.
• Develops and implements projects from concept to completion.
Qualifications and Skills
• Two-year degree with 6+ years related experience or equivalent combination of education and technical work experience. May also require a license or certification in the area of expertise.
• Applies extensive knowledge of complex technical concepts and practices, and a complete understanding of product or systems fundamentals in a functional area, and working knowledge of other related disciplines.
• Utilizes/interprets advanced numerical and statistical data and/or computer software programs to present documentation and analysis and resolve production, technical, or systems problems.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Performs extremely complex or specialized technical assignments usually in the nature of projects, requiring working independently.
• May design, develop, or modify area-specific equipment, materials, systems, and/or product.
• Assignments require considerable judgment, high degree of initiative, creative approaches in troubleshooting, and making recommendations for continuous quality improvement of work methods for functional area.