Boehringer Ingelheim Senior Process Engineer, Upstream Manufacturing (Cell Culture) in FREMONT, California
The Senior Process Engineer's job is to evaluate, transfer and implement new processes into the GMP facility and to drive trouble shooting and continuous improvement activities/projects. Process/tech-transfers cover internal projects within Boehringer Ingelheim, external projects from clients (Contract Manufacturing Business) in early or late clinical phase as well as for launch and commercial supply. The position is responsible for planning and executing process transfers in a cross-functional project organization. This includes providing scientific and technological input and guidance as expert on site and within the global Biopharma.
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:
Perform process/technology transfer for assigned projects and supervise projects over time until commercial phase.
Take over more complex process transfers
Give scientific and technical guidance in process transfers
Give supervision to junior process engineers
Collaborate with other team members in cross-functional transfer teams, with international customers and lead of BI sub-teams.
Responsible for performing the process evaluation and facility fit including materials, and identifying required equipment for new processes to be implemented in the GMP-manufacturing facility.
Support Requests for Proposals from potential customers
Perform scale-up with required adaptions and process improvements
Plan process-transfer activities according to timeline and quality
Ensure optimal process design for maximal facility output to support competitiveness
Manage technical interfaces with national and international clients and BI internal units (Process Science, Quality Assurance and Control, Supply Chain Management, Engineering and Technology, Project Management, Manufacturing, etc.).
Be the single point-of-contact for respective technical clients
Discuss and present results to internal or external customers to successfully transfer processes
Design and planning of small-scale studies in collaboration with Process Science during transfer runs
Perform technical assessments
Contribute to New Product Introductions and technical risk analyseis
Be point of contact for overall process validation planning and execution
Be part of planning process characterization studies
Support filing documents, write and review sections within CMC dossiers
Process monitoring /trending
Monitor, analyze and evaluate process data and trends
Closely collaborate with Process Science on internal improvement projects
Create campaign reports
Conduct complex trouble shooting related to production (e.g., technical, equipment, and process performance issues, including planning of small-scale testing in collaboration with Process Sciences and/or Manufacturing Sciences and Technology
Ensure that investigations are consistent with manufacturing practices (process and methods), policies and complying with external regulatory requirements.
Manufacturing specific technology
Provide input on how to maintain and improve plant technology
Continuous improvement of business and manufacturing processes
Introduction of new technologies for manufacturing
Mammalian Cell Culture Technology, Bioengineering Technology, Project Management, Good communication skills
Bachelors Degree with 6-8 years/Masters Degree with >3 years of professional experience or equivalent
Desired Experience, Skills and Abilities:
- Experience with cross functional teams
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
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Organization: US-BI Fremont
Title: Senior Process Engineer, Upstream Manufacturing (Cell Culture)
Location: Americas-United States-CA-Fremont
Requisition ID: 1612354