Job Information
Boehringer Ingelheim SR / Principal Engineer, Process in St. Joseph, Missouri
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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. The SR Engineer, Process has the responsibility of providing manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new equipment, facilities, and/or utilities.
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 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.
Responds to requests for support from production.
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 Principal Process Engineers in the execution of small-scale capital projects up to around $500,000, process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects).
On larger capital projects, the engineer will work with Capital Engineering and Equipment Vendors to ensure 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.
SR Engineer 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
Communication
Customer Focus
Decision Making
Planning and Organizing
Teamwork
Conceptual / Analytical Thinking Scope
Delivering Results
Leadership
Principal Engineer Requirements
Requires a Bachelor's Degree from an accredited institution with a minimum of eight (8) years direct experience
A Master's Degree will be considered with greater than five years of professional experience or equivalent
Experience must include four (4) years relevant industry experience in cell biology, cell culture technology, protein purification, protein chemistry and/or bioengineering.
Operational experience in biopharmaceutical drug substance manufacturing.
Expertise in tech transfer, GMPs, facility fit, cell biology, cell culture technology, protein purification, protein chemistry and/or bioengineering.
Excellent oral and written communication skills
Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent communication skills, team player, organized analytical thinker with a high level of energy and self-motivation.
Ability to read, develop, and understand procedures and other controlled documents
Must have excellent written and verbal communication skills, including technical writing.
Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
Intermediate MS Outlook, Word and Excel skills.
Working knowledge of applicable Regulatory requirements (cGMP, DEA, OSHA, BOCA, EPA) and contract law
Preferred experience in Bioengineering Technology, Manufacturing and Business Process Excellence tools (Six Sigma)
Project Management skills
General management skills
Eligibility Requirements
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.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.