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Associate Engineer, DS Plant Engineering

Company: Boehringer Ingelheim
Location: Fremont
Posted on: June 9, 2021

Job Description:

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-MS1

Description:

The Associate Engineer, DS Plant Engineering assists in ensuring process equipment readiness in BI Fremont's GMP manufacturing facility for the manufacture of biopharmaceutical drug substance. This includes troubleshooting and identifying potential improvements in mechanical and automation functionalities of production equipment.

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:

  • Assists in the identification and implementation of new manufacturing equipment or modifications to optimize existing processes and ensure achievement of regulatory and safety requirements. Assists with the pre-production readiness program with regard to wet run checklists, equipment checklist, tracking the use of assets in collaboration with area owners. Coordinates equipment readiness within manufacturing. Activities include the testing of the equipment with the appropriate procedures to confirm it will perform as expected in the GMP runs as part of the New Product Introduction process.
  • Assists with technical troubleshooting of mechanical and automation issues. Implement new or adjusted solutions to increase the reliability and availability of equipment in the assigned department.
  • Assists with equipment-related training programs.
  • Perform at scale process studies, i.e. mixing studies, media hold studies, to support process improvements and equipment validation.
  • Own and execute CAPAs with regard to process equipment operations and on-going validation.
  • Provide technical input and review for CAPEX projects as user engineers.
  • Ensures compliance with all manufacturing processes in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives.
  • Demonstrates good knowledge of GMP, FDA and European regulations. Follow all relevant department policies, procedures, SOP and other requirements during project execution and act at all times within the BI standards/ethics policies.

Requirements:

  • High School Degree, with six (6) years' experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
  • Associate's degree from an accredited institution in the area of Life Sciences or closely related discipline, plus five (5) years of manufacturing experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
  • Bachelors Degree from an accredited institution in the area of Life Sciences or closely related discipline, with greater than two (>2) years of related professional in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
  • Must be able to demonstrate basic understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation
  • Understanding of facility technology, system troubleshooting using root cause analysis tools, CAPA's and change controls highly preferred
  • Has some knowledge of equipment testing and readiness, project management, CAPA's, Deviations, CAPEX and New Product Introduction process.
  • Must have strong communication skills to communicate and oversee equipment modifications in conjunction with our maintenance staff
  • Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.
  • Projects are cross functional and the project scope is limited.
  • Should be able to independently influence peers to achieve a common goal
  • Experience writing SOPs, protocols, deviations and processes
  • Be able to multi-task and be organized
  • Experience in biotech, pharmaceutical manufacturing or device manufacturing is a requirement. Preferably experience being a manufacturing operator or technician
  • Possesses knowledge in the area of mammalian-based biopharmaceutical manufacturing processes. Has limited experience in managing projects.
  • Possesses some knowledgeable about interdisciplinary processes.
  • Possesses knowledge of cGMP systems and regulations.

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

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.

#LI-MS1

#PDN2

  • I-SF1

'623018

Keywords: Boehringer Ingelheim, Fremont , Associate Engineer, DS Plant Engineering, Other , Fremont, California

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