Principal/Senior Engineer, Process

Boehringer Ingelheim is a global leader in the pharmaceutical industry, committed to delivering innovative solutions for patients and customers. The Principal Engineer, Process will provide manufacturing support for current processes and lead process improvement initiatives, ensuring effective communication between production and engineering teams.

Responsibilities:

• Facilitates changes to existing production processes
• Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment
• Assists validation of new equipment and changes to existing equipment including document generation
• Acts as change control owner for equipment and process improvement projects
• Coordinates change control meetings
• Assigns action items for change control
• Accountable for closing out change control action items and documentation. Documentation includes P&ID drawings, functional specifications, detailed design specifications, Turn-over-packages, material specifications, and other documentation as required
• Supports manufacturing in troubleshooting product and equipment issues
• 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 $500,000
• Leads process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects)
• 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
• May be responsible for leading, directing, coaching, and developing up to seven junior engineers within the site's process engineering organization

Requirements:

• Bachelor of Science Degree in Engineering or related science from accredited school
• In addition to degree, a minimum of four (4) years applicable experience, engineering or scientific in nature in a cGMP environment or similarly regulated environment
• Minimum of seven (7) years engineering or scientific experience outside of a cGMP/non-regulated environment
• Experience must be inclusive of at least (3) three years leading moderate to complex CAPEX, process improvement, and/or related engineering projects
• 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
• 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
• 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
• Experience with GAMP Automation practices and documents preferred