Associate Engineer, DS Plant Engineering
Company: Boehringer Ingelheim
Posted on: June 9, 2021
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
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
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
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
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
- Assists with equipment-related training programs.
- Perform at scale process studies, i.e. mixing studies, media
hold studies, to support process improvements and equipment
- Own and execute CAPAs with regard to process equipment
operations and on-going validation.
- Provide technical input and review for CAPEX projects as user
- 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.
- High School Degree, with six (6) years' experience in a cGMP
pharmaceutical manufacturing environment with positions of
- 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
- 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
- Has some knowledge of equipment testing and readiness, project
management, CAPA's, Deviations, CAPEX and New Product Introduction
- Must have strong communication skills to communicate and
oversee equipment modifications in conjunction with our maintenance
- 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
- Should be able to independently influence peers to achieve a
- Experience writing SOPs, protocols, deviations and
- 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
- Possesses knowledge of cGMP systems and regulations.
- Must be legally authorized to work in the United States without
- Must be willing to take a drug test and post-offer physical (if
- 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.
Keywords: Boehringer Ingelheim, Fremont , Associate Engineer, DS Plant Engineering, Other , Fremont, California
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