Abbott Laboratories
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 114,000 colleagues serve people in more than 160 countries.
MAIN PURPOSE OF ROLE Supports production and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing process development and qualification, equipment specification, acquisition, installation, and integration.
MAIN RESPONSIBILITIES
Interface with internal customers to provide controls support for manufacturing and testing equipment
Support the development and maintenance of automated equipment
Evaluate process and design alternatives based on Design for Manufacturability principles
Establish knowledge base of new developments in manufacturing and design technologies
Interface with vendors on procuring materials, services, and equipment
Assemble and evaluate automated equipment
Establish machine specifications
Support equipment validations
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment and identify process improvement opportunities
May conduct design analysis on components and/or assemblies to assist in the development process by ensuring designs are cost efficient, manufacturable, and reliable
Communicates with the other engineering personnel to coordinate the interrelated design and assure project completion
May act as internal consultant providing technical guidance on most complex projects
This is a non-supervisory position
Coordinate and participate in equipment Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), etc.
Conceptualize, design, and build complete solutions for novel or complex problems; explore multiple alternatives
Programming and integration of controls hardware and software into new and existing manufacturing equipment
Analyzes current equipment for process suitability and provides detailed plans for improvement
Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures
Lead cross functional project teams and coordinate activities
Analyzes, creates and implements manufacturing and/or business process improvements that increase capacity, reduce lead-time, reduce work in process and improve the quality, cost and delivery performance of Abbott
Investigate and resolve existing equipment operating, reliability, and yield issues and implement corrections or modifications to ensure systems operate within qualified parameters. Create and execute Quality System records to ensure equipment performance history is properly documented
QUALIFICATIONS
Hands on working knowledge of automation control software and PLC programming and troubleshooting
Strong knowledge and experience in industrial robotics, Servos, Pneumatic systems, sensors, and Machine Vision systems
Familiarity with qualification and regulatory requirements in the medical device industry, including Design Review, User Requirement Specifications (URS), IQ/OQ/PQ, etc
Associates Degree (± 13 years) with Related with 10-15 years relevant experience
Bachelors Degree Engineering
EXPERIENCE
Minimum 5 years
5-10 years as automation controls engineer
Must have experience with designing and fabricating automated production equipment for low and high volume processes. Good communication skills and the ability to interact with all levels of the organization. Experience with general automation and control concepts along with machine vision systems, robotics, and PLC software programming
Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow‑up skills, as well as attention to detail. Ability to travel, including internationally
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
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MAIN PURPOSE OF ROLE Supports production and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing process development and qualification, equipment specification, acquisition, installation, and integration.
MAIN RESPONSIBILITIES
Interface with internal customers to provide controls support for manufacturing and testing equipment
Support the development and maintenance of automated equipment
Evaluate process and design alternatives based on Design for Manufacturability principles
Establish knowledge base of new developments in manufacturing and design technologies
Interface with vendors on procuring materials, services, and equipment
Assemble and evaluate automated equipment
Establish machine specifications
Support equipment validations
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment and identify process improvement opportunities
May conduct design analysis on components and/or assemblies to assist in the development process by ensuring designs are cost efficient, manufacturable, and reliable
Communicates with the other engineering personnel to coordinate the interrelated design and assure project completion
May act as internal consultant providing technical guidance on most complex projects
This is a non-supervisory position
Coordinate and participate in equipment Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), etc.
Conceptualize, design, and build complete solutions for novel or complex problems; explore multiple alternatives
Programming and integration of controls hardware and software into new and existing manufacturing equipment
Analyzes current equipment for process suitability and provides detailed plans for improvement
Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures
Lead cross functional project teams and coordinate activities
Analyzes, creates and implements manufacturing and/or business process improvements that increase capacity, reduce lead-time, reduce work in process and improve the quality, cost and delivery performance of Abbott
Investigate and resolve existing equipment operating, reliability, and yield issues and implement corrections or modifications to ensure systems operate within qualified parameters. Create and execute Quality System records to ensure equipment performance history is properly documented
QUALIFICATIONS
Hands on working knowledge of automation control software and PLC programming and troubleshooting
Strong knowledge and experience in industrial robotics, Servos, Pneumatic systems, sensors, and Machine Vision systems
Familiarity with qualification and regulatory requirements in the medical device industry, including Design Review, User Requirement Specifications (URS), IQ/OQ/PQ, etc
Associates Degree (± 13 years) with Related with 10-15 years relevant experience
Bachelors Degree Engineering
EXPERIENCE
Minimum 5 years
5-10 years as automation controls engineer
Must have experience with designing and fabricating automated production equipment for low and high volume processes. Good communication skills and the ability to interact with all levels of the organization. Experience with general automation and control concepts along with machine vision systems, robotics, and PLC software programming
Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow‑up skills, as well as attention to detail. Ability to travel, including internationally
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
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