Senior Analyst, Manufacturing Process

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Responsible for management of Production projects that improve manufacturing efficiency and safety, decrease costs, decrease opportunity for human error, or increase compliance. Works in concert with peers in other departments to meet project timelines. Responsible for tracking the transfer, implementation and monitoring of projects. Uses SAP, LIMS, PI, and other systems, programs, and databases to input, verify, monitor and analyze pertinent data.

Able to identify opportunities for improvement of manufacturing and business processes. Proposes, plans and facilitates the implementation of improvement solutions. Responsible for Inventory maintenance and production tracking.

Responsibilities

• Applies knowledge, experience and technical skills to understand Production objectives, to provide support to Production initiatives, to execute systems and procedures efficiently and compliantly, evaluates systems for improvement potential. Use standard practices to ensure inter-group consistency. Works, within established systems to improve Good Manufacturing Practices (GMP) compliance.
• Schedules work tasks, with limited assistance, to support project/campaign timelines. Circulates documents to reviewers with limited assistance, responds to comments and questions. Manages document review and approval to meet project timelines.
• Exercises judgment within generally defined procedures and practices to determine appropriate action. Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.
• Assist in the execution of validation activities for the manufacturing equipment. Provide technical assistance related to the manufacturing equipment. Assist in the troubleshooting of the manufacturing equipment.
• Establish requirements and assist in the implementation of changes to the Process Control System.
• Investigates events in production that have quality or compliance impact. Leads or participates in RCPS or FMEA sessions. Documents investigation outcomes.
• Transfers methods into Production instructions. Provides training to ensure successful rollout of new methods.
• Responsible for Inventory maintenance and production tracking. Subject matter expert in SAP for inventory and production. Track and report bulk usages. Support production in inventory management. Interface with Planning to create and manage production process order numbers and batch numbers. Initiate and track blanket purchase orders for goods and services to support production. Track weekly and monthly yield performance and report to Department supervision and Finance.
• Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
• Comply with Abb Vie policies and procedures, Engineering Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.

• Bachelor’s Degree or equivalent required, preferably in an engineering or related field.
• At least 5 years’ experience in all aspects of manufacturing/production processes with good writing skills.
• A working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility is required. Familiarity with pertinent regulatory filings. Proficiency with tech transfer process and familiarity with equipment and facilities validation
• Must be…