SR Engineer, Process

Facilitates changes to existing production processes.

Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment.

Assists with validation of new equipment and changes to existing equipment including document generation.

Acts as change control owner for equipment and process improvement projects. Coordinate change control meetings.

Assigns action items for change control.

Accountable for change control action items and documentation. Documentation includes drawings, functional specifications, detailed design specifications, Turn-over-packages, material specifications, and other documentation as required.

Supports troubleshooting product and equipment issues in production areas such as biomanufacturing, formulation and filling, lyophilization and packaging.

Identifies improvements to manufacturing process. Improvements may include mechanical, automation, or workflow.

Works with manufacturing and capital engineering on the development of future capital projects and on the development of requirements for the project.

Responsible for User Requirement Specification development.

Assists cross functional teams in the execution of small-scale capital projects up to around $500,000, process improvement projects, continuous improvement projects, and equipment improvement projects.

On larger capital projects, the engineer will be responsible for to ensuring process requirements are communicated and built into the equipment/system design. The engineer will develop specifications (user, functional, and detailed design) for equipment and automation of the equipment.

Develops and maintains overall knowledge of facility processes and products.

Provides training on process and/or equipment modifications as required for new or existing equipment/processes.

Acts as Subject Matter Expert for production equipment and processes for Capital Engineering, Production, Business Process Science, Quality Assurance, and Maintenance.