SR Engineer, Process

Boehringer Ingelheim Pharmaceuticals, Inc.; Athens (GA); On-site; USD 85,000 - 115,000; Full time

Job summary

Boehringer Ingelheim is seeking a process/ manufacturing engineer to contribute to production through changes, equipment upgrades, and validation activities. The role emphasizes working within GMP environments and coordinating with cross-functional teams.

The position involves supporting biomanufacturing, formulation, lyophilization, and packaging processes, including capital projects up to $500k and newer automation developments. Strong documentation and leadership skills are essential.

Qualifications

• Bachelor of Science in Engineering with 1–3 years in GMP environment or 3–5 years in non-GMP environment
• Master's Degree with 1 year GMP experience or 1–2 years non-GMP experience
• At least 1 year of leading projects preferred

Responsibilities

• Facilitates changes to production processes
• Leads installation, commissioning and start-up of new equipment
• Assists with validation of new equipment and changes
• Manages change control for equipment and process improvements
• Develops user and functional specifications for equipment and automation
• Supports troubleshooting in manufacturing areas such as biomanufacturing and filling

Skills

Analytical Thinking

Data collection and analysis

Communication

Customer Focus

Data-driven Decision Making

Planning and Organizing

Teamwork

Leadership

Problem Solving

Education

Bachelor of Science in Engineering

Master's Degree in relevant field (GMP)

Tools

GAMP Automation standards

Job description

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.

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

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long‑term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com