Boehringer Ingelheim is a global company dedicated to the discovery, development, and delivery of innovative therapies. The Senior Principal Engineer, Process will serve as a Subject Matter Expert in aseptic manufacturing, providing support and leadership in process development, troubleshooting, and capital projects.
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
Requirements:
- Bachelor's degree in Engineering or related field with ten (10) years of experience in a relevant scientific discipline
- OR 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
- 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