Device & Packaging Engineer, Drug Product-219381
Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim’s Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.
We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs.
Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim’s unique experience of having brought 30+ biologics to market globally.
Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.
Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches – Everything we do, we do to help patients! #LI
The Device & Packaging Engineer is responsible to evaluate, transfer and implement new assembly and packaging processes for combination product including device components and secondary packaging materials into the GMP facility and to drive trouble shooting and continuous improvement activities/projects. The position is responsible for driving change management of Design Control and Risk Management of combination product including pre-filled syringes and auto-injectors. This also includes successful completion of design, development and commercialization deliverables with interaction with Innovation Unit and ensuring that device design, machinability and testing specifications and methods meet product needs.
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 a number of 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.
Duties & Responsibilities:
- Lead process/tech transfer for assigned projects with internal assistance according to timeline and quality until the commercial phase.
- Primary contact to review and approve transfer documentation from the sending site unit – Biberach and Ingelheim and implementation at the process receiving site-BI Fremont.
- Drive the local development and qualification of device components, packaging materials and labels including creation and maintenance of customer/purchasing specifications for device components, packaging materials and labels.
- This includes creation and execution of material-equipment machinability/processability testing protocols as part of material qualification.
- Lead process characterization studies and support equipment engineering runs including FATs, SATs and IOPQ as part of equipment qualification.
- This also comprises equipment and process risk assessments, validation master plans, control strategies and process performance qualification technical support.
- Execute artwork management and change management workflows for regulatory submissions, commercial printed packaging materials, commercial product SKUs including creation and maintenance of technical drawings for printed packaging materials and artwork management.
- Provide technical expertise on device design and development planning, design control and design transfer activities for combination product, including the creation, review and approval of source document.
- Maintain local design control documents and ensure alignment with design control landscape through development and lifecycle management.
- Drive local change management activities for device design control, new product introductions, product launch and change implementations and continuous improvement activities.
- Provide subject matter expertise for Supplier Change Notifications and drive subsequent change management workflows.
- Provide assistance in deviation investigation by leading root-cause-analysis activities and identification of CAPAs.
- Drive CAPAs and continuous improvement activities to maintain compliance with drug, biologics and combination product regulations, industry standards and guidelines.
- Author, review and maintain technical documents per ICH guidelines for registration of products to health authorities.
- Ensure compliance of all manufacturing activities with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Goals and Objectives.
- Demonstrates expertise of GMP, FDA and European regulations.
- Follows all relevant department relevant department policies, procedures, SOP and other requirements during manufacturing execution and act at all times within the BI standards/ethics policies.
- Strong understanding and appreciation for regulatory requirements and compliance standards under which Fremont site is operating.
- Coordination and communication between multiple departments, including Process Science, Quality and other functional areas.
- Requires a Bachelor’s degree from an accredited institution, preferably in a life science or engineering related field with four (4) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility, plus a minimum of two (2) years of experience as a manufacturing engineer in a GMP environment or clean room assembly environment.
- Would consider Master’s degree from ac accredited institution, preferably in a life science or engineering related field with two (2) years of cGMP pharmaceutical manufacturing experience as a device manufacturing engineer in a GMP environment.
- The position requires the ability to multitask.
- The ability to troubleshoot issues, problem-solving skills.
- Strong organizational skills.
- Ability to communicate clearly and accurately.
- Ability to work in a team setting as well as an individual contributor.
- Ability to work cross functionally in a dynamic, high-pressure environment.
- Experience in assembly and packaging technology, as well as the industry trends in this area. Knowledge in bioengineering technology and project management
- 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
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. 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.
– Manufacturing/Operations/ Production
– US-BI Fremont