Purpose Statement

• Performs functions associated with current Good Manufacturing Practices manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials.
• Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment.
• Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Major Responsibilities:

• Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.
• Schedules work tasks, with general assistance, to support project and campaign timelines. Drafts moderate scope and complexity documents. Circulates documents to reviewers with general assistance, responds to comments and questions. Manages document review and approval to meet project timelines and provides status reports to management.
• Works with management and senior staff to determine appropriate course of action within defined procedures. Tracks ongoing problems and gathers information for analysis. Analyzes data to develop solutions to moderate-level problems.
• Applies knowledge, experience, and technical skills to understand ABC production objectives, to provide support to production initiatives, to execute procedures efficiently and compliantly, and use standard practices to ensure inter-group consistency.
• Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
• Exercises judgment within defined procedures and policies to determine appropriate action. Discusses action with senior staff.
• Coordinates activities of sub-group and actively works with other sub-groups. Frequently interacts with subordinates and supervisor.