Primary Function/Primary Goals/Objectives:

　　Lead Food Safety risk assessment and quality records (QRs) for escalation on lines as per Global GMP lifecycle policy.

　　Provides support and inputs to update Food Safety Policy and site HACCP.

　　Provide support to the Manufacturing organization to facilitate the efficient operations within the production area.

　　To optimize existing processes and to ensure that production goals are met. Ensures systems and processes to maintain GMP at workplace.

　　Collaborate with Operations sub-functions in tracking critical production and cleaning parameters to track and collate responses for consumers/medical/affiliates escalations.

　　Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that can produce non-conforming products.

　　Major Responsibilities:

　　Responsible to Manage and focus directly on GMP food safety engineering/food security and validation, in preparation for the commercial production of regulated products.

　　Lead projects of facilities and equipment and optimization of existing manufacturing processes to deliver products with the production requirements consistent with Gold Standard Policies.

　　Responsible to perform quality events investigation and coming up with CAPA action. Ensuring the effectiveness of CAPA action.

　　Responsible to Motivate, develop and train employees for the facility and from third party as part of food safety program.

　　Lead incident reviews to investigate and correct microbiological non-conformities and provide recommendation regarding process design, product disposition and continuous improvement.

　　Optimize the documentation for quality systems, cleaning and validation, SOPs, HACCP plans, and food safety policy and protocols.

　　Ensures plant Food Safety documentation is maintained in an audit-ready state, meeting all statutory, regulatory requirements & customer expectations.

　　Ensures the effective use of materials, equipment, and personnel in producing quality products at an effective operating cost.

　　Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.

　　Prepares reports, publishes, and makes presentations to communicate findings.

　　Partner with Engineering on the installation, modification, upgrade and maintenance of manufacturing equipment.

　　Implement, document, and maintain controlled, repeatable production processes.

　　Development of qualification and validation protocols.

　　Participate in and/or lead qualification and validation activities.

　　Interface with other departments and suppliers to address root causes.

　　Understands the business needs of the company and has knowledge of the customer needs of our business.

　　Cultivates internal and external network of resources to complete tasks.

　　Any other duties as assigned by supervisor.

　　Skills/ Experience Requirements:

　　1 to 4 years of related experience.

　　Knowledge in SAP system/POMS/MES.

　　Knowledge about food microbiology, pathogens and food safety.

　　Able to make fast decision and react efficiently to situation.

　　Understands engineering principles, theories concepts, practices and techniques

　　Education:

　　Bachelor’s degree in Process Engineering/ Mechanical/ Electrical/ Food Science

　　Biotechnology/Microbiology or in related discipline or with a minimum 1-4 years of related experience.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]