Master MFG Associate, Upstream
Company: Boehringer Ingelheim
Posted on: June 22, 2022
Description:Description\: -Executes and coordinates unit
operations in Upstream manufacturing as assigned related to the
manufacturing of bulk drug substance in a multi-product facility.
Performs duties under limited supervision and according to standard
operating and manufacturing procedures. Serves as an operations
subject matter expert (SME) representing the department during
audits, new product introductions, and technical assessments. - - -
- - - - - -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\:
- Independently executes complex unit operations including but
not limited to batching and inoculation of bioreactors, operation
of bioreactors, process monitoring, and harvest operations.
Supports equipment and process troubleshooting and implements
continuous improvement projects of low to moderate complexity in
the production areas. Defines user requirements for new equipment
and validation protocols. - -
- Executes independently with adequate training fundamental
- CIP/SIP of bioreactors, tanks, and harvest equipment.
- Media preparation and transfer into tanks and disposables.
- Cell inoculation and transfer.
- Daily analytics and maintenance of analytical equipment.
- May be required to support parts cleaning and weigh and
- Performs internal support duties including stocking
consumables/materials, updating controlled SOP binders,
appropriately discarding expired reagents, recognizing and
reporting process and equipment anomalies.
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established
- Reports abnormalities and deviations in a timely and accurate
- Adheres to safety standards and identifies unsafe situations /
habits and escalates appropriately.
- Maintains production areas according to predefined standards
- Maintains own training within compliance and trains other
technicians and associates on operations upon completion of trainer
qualification. Conducts group trainings on complex topics and
scientific principles as needed.
- Contributes to Quality activities as investigations and area
- High school degree plus minimum four (4) year's work experience
in GMP regulated industry
- Associates/Bachelor's degree from an accredited institution or
biotechnology vocational training preferred.
- Four (4) or more years of experience in cGMP regulated
- Ability to concentrate on detail oriented work in a complex
technical setup with a Quality and Right the first time
- Strong written and verbal communication skills.
- Ability to work with computer-based systems and ideally
experience with process control systems (e.g. Delta V) and
manufacturing execution systems (MES).
- Ability to read and understand SOPs and work instructions and
document work in a written format applying cGMP standards.
- Ability to work as part of a high performing team and
collaborate effectively with staff.
- Strong working knowledge of biopharmaceutical manufacturing
practices, as well as a strong understanding of biologics
principles are required.
- Working in a highly regulated environment following all
applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and
- Required to work according to given schedules in a 24/7 shift
structure and flexibility to adapt working schedule upon prior
given notice.Eligibility Requirements\:
- 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 olderWho 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 , Master MFG Associate, Upstream, Other , Fremont, California
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