SR Engineer, Process

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

The SR Engineer, Process has the responsibility of providing manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new equipment, facilities, and/or utilities.

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 Scope

Delivering Results

Leadership

Desired Skills, Experience and Abilities