SR Engineer, Process

Boehringer Ingelheim GmbH; Athens (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Boehringer Ingelheim is seeking a SR Engineer, Process in Athens, GA to support current manufacturing processes and lead improvements in biomanufacturing, formulation, lyophilization and packaging. You will help install new equipment, validate changes, and drive capital projects while working with cross-functional teams to ensure GMP compliance.

The role requires strong communication, planning, and leadership skills to coordinate change control and document development.

Qualifications

• Bachelor's degree in Engineering with 1–3 years GMP or 3–5 years outside GMP.
• Master's degree with 1 year GMP or 1 year engineering / 2 years non-GMP.
• At least 1 year leading projects.
• Effective verbal and written communication across levels of corporate and local management.

Responsibilities

• Facilitates changes to existing production processes.
• Accounts for installation, commissioning, startup of new equipment.
• Assists with validation and documentation of equipment changes.
• Acts as change control owner for equipment projects. Coordinate change control meetings.
• Assigns action items for change control.
• Accountable for change control documentation including specs and turnover packages.
• Supports troubleshooting in production areas such as biomanufacturing, formulation, lyophilization, and packaging.
• Identifies improvements to manufacturing process (mechanical, automation, or workflow).
• Works with manufacturing and capital engineering on future capital projects and requirements for the project.
• Assists cross functional teams in small-scale capital projects up to around $500,000.
• Develops and maintains knowledge of facility processes and products.
• Provides training on process/equipment modifications as required.
• Acts as SME for production equipment and processes across departments.

Skills

Analytical Thinking

Data collection

Analysis

Communication

Customer Focus

Data-driven Decision Making

Planning and Organizing

Teamwork

Conceptual Thinking

Leadership

Education

Bachelor of Science in Engineering

Job 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.
• 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.
• 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