SR Engineer, Process

Duties & Responsibilities

• 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.

Requirements

• Bachelor of Science Degree in Engineering from an accredited school with one to three (1-3) years applicable experience in a GMP environment or Bachelor´s degree with three to five (3-5) of engineering or scientific experience outside of a GMP environment.
• In lieu of years of experience, Master´s Degree in relevant field from an accredited school with one (1) year experience in a GMP environment or at least one (1) year of engineering or two (2) years of scientific experience outside of a GMP environment.
• At least one (1) year of experience leading projects preferable.

Competencies

• Effective verbal and written communication with all levels of corporate and local management and employees.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to understand and work within a regulated environment.
• Experience with GAMP Automation practices and documents preferred.
• Ability to function in a leadership role as well as in a team environment.
• Ability to manage multiple projects at one time.

Skills

• Analytical Thinking
• Data collection and analysis
• Communication
• Customer Focus
• Data-driven Decision Making
• Planning and Organizing
• Teamwork
• Conceptual / Analytical Thinking
• Delivering Results
• Leadership

Scope

• Delivering Results
• Leadership