Sr. Manufacturing Process Engineer

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

We are seeking a high caliber Sr. Process Engineering to provide engineering support for new and existing equipment and processes used in Abbott Molecular’s manufacturing operations.  Responsible to develop and implement equipment upgrades and modifications to reduce product costs and improve product quality. Participate in and lead project teams requiring engineered solutions for new equipment, products, or processes.  Implement, document, and maintain controlled, repeatable production processes.

Impact this role will have on Abbott

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Manage capital projects to select, design, procure, install and qualify new manufacturing equipment. 
• Assist with developing Capital Long Range Planning for site and authoring request for capital expenditure.
• Work with equipment suppliers to establish project requirements, deliverables, and budgets and implement according to agreed timelines. 
• Coordinate the creation and execution of qualification and validation protocols to verify equipment capabilities.
• 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.
• Maintain relationships with contractors and equipment suppliers and service staffs.
• Direct the activities of these third-party resources to ensure equipment operates as intended. 
• Routinely has direct contact with outside consultants, technical staff from key suppliers and engineering staff in other divisions.
• Create or modify documentation requiring engineering technical knowledge. 
• Includes operating procedures to be used by manufacturing personnel, qualification and validation protocols and executions, equipment preventive maintenance procedures, and material specifications.
• May perform other duties as assigned.

Accountability / Scope:

• Position is accountable for successful implementation of engineering projects with capital investment from $50,000 - $2 million. 
• Accountable for project budgets and associated cost reduction of $10-$500 thousand per year. 
• Position operates with limited supervision. 
• Successful execution of the responsibilities associated with this position results in improving yields and cost metrics, and conformance with site, corporate and regulatory requirements. 
• Failure in position may impact overall division operations and compromise product quality and/or supply chain delivery. 

Qualifications:

• B.S. in any Engineering discipline or equivalent experience.
• 4-6 years experience, preferably in a mid-volume manufacturing environment, to include some or all of the following:
• Medical device manufacturing experience preferred.
• Progressive experience with equipment specification and procurement with emphasis on process and packaging manufacturing solutions, small volume liquid filling, capping, torqueing, label printing, application and inspection systems.
• Familiarity with qualification and regulatory requirements in the medical device industry, including Design Review, User Requirement Specifications (URS), FAT, SAT, IQ/OQ/PQ, ISO 8, etc.
• Hands on working knowledge of automation control software and PLC programming and troubleshooting. Preferably Allen-Bradley and Siemens.
• Ability to communicate effectively and engage cross functional team on all aspects and responsibilities required of equipment installation and qualifications.
• Experience using a computerized maintenance management systems (CMMS) such as Maximo.
• Experience with CAD programs such as AutoCAD, SolidWorks, etc.
• Experience with MS Project and SAP. PMP certification beneficial but not required.
• Strong mechanical and electrical aptitude.
• 10% Travel required for equipment acceptance, Field Acceptance Testing (FAT), etc.

JOB FAMILY:

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