SR Principal Engineer, Process

BoehringerPRD•Saint Joseph, MI

13d

About The Position

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 Senior Principal Engineer, Process will serve as a process-specific Subject Matter Expert (SME) for one or more aspects of the aseptic manufacturing process, including but not limited to Active Ingredient Production, Filling, Freeze Drying, and Packaging. The incumbent’s expertise is applied by providing direct manufacturing support and troubleshooting of current processes as well as serving as technical and/or overall lead for capital projects involving the installation of new or modification of existing equipment, facilities and/or utilities.

Requirements

Bachelor’s degree in Engineering or related field with ten (10) years of experience in a relevant scientific discipline.
Master's degree, eight (8) years of experience in a relevant scientific discipline.
Ability to communicate verbally and in writing effectively 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.
Ability to function in a leadership role as well as in a team environment.
Ability to manage multiple projects at one time.
Ability to directly manage one or more internal or external resources.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

Nice To Haves

Eight-plus (8+) years applicable experience engineering or scientific in nature in a GMP environment.
Experience with GAMP Automation practices and documents.
Basic working knowledge of Allen-Bradley and/or Siemens PLCs (Programmable Logic Controllers).
Lean Six Sigma Green Belt (or higher) certification.
Certified Maintenance & Reliability Professional (CMRP) certification.
Five-plus (5+) years’ experience leading projects.
Experience using, developing, and leading recognized process optimization tools in a manufacturing facility.

Responsibilities

Demonstrates and directly applies SME-level mastery of process-specific engineering principles in solving vaccine manufacturing challenges varying in both scope and complexity.
Leads process development, modification, and optimization efforts on a large scale and drives actions that require the buy-in and support from multiple other functions including but not limited to Operations, Quality, Project Engineering, and Maintenance (PME).
Cross-functional leadership capability is essential.
Supports manufacturing in troubleshooting product and equipment issues on a large-scale.
Drives the communication process between production and process engineering to identify issues with the manufacturing process and find long term solutions to these issues.
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.
Leads small scale capital projects up to around $1M annual spend, primarily those with heavy technical components.
Accountable for following capital process procedures and execution of project regarding cost and schedule.
On larger capital projects, works with Capital Engineering and Equipment Vendors to ensure process requirements are communicated and built into the equipment/system design.
Develops 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.
Educates and mentors other process engineers, technicians, etc. to foster a continuous effort to bring others to the same level of expertise.