Boehringer Ingelheim · 3 months ago
Principal/Senior Engineer, Process
United States
Full-time
Remote
Senior Level, Lead/Staff
1+ years expBoehringer 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.
BiotechnologyHealthcarePharmaceuticalHealth CareMedical
No H1B
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
Qualification
Required
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
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
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
Preferred
Experience with GAMP Automation practices and documents preferred
Benefits
Competitive compensation and benefit programs
Company
Boehringer Ingelheim
Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.
Founded in 1885Ingelheim Am Rhein, Rheinland-Pfalz, DEU
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Christian Eckermann
Corp. SVP BioPharma Network
Clemens Twardy
Corporate Vice President, Head of Global Supply Chain and Lifecycle Management Animal Health
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