US_MFG Associate, Downstream
Company: Boehringer Ingelheim
Posted on: July 30, 2022
Description\: Executes routine unit operations in Downstream
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. 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\:
- Executes, with oversight of qualified staff, complex unit
operations including but not limited to chromatography operations,
tangential flow filtration, various filtration methods, and process
- Executes independently with adequate training fundamental
- CIP/SIP of tanks, transfer lines, and process equipment.
- Buffer preparation and transfer into tanks and
- Performs In process testing for samples e.g. spectrophotometry,
pH, conductivity, and maintenance of analytical equipment.
- This may include parts cleaning and weigh and dispense.
- 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
- Contributes to Quality activities as investigations and area
- High school degree plus minimum one (1) year work experience in
GMP regulated industry
- Associates/Bachelor's degree from an accredited institution or
biotechnology vocational training preferred.
- One (1) 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.
- Basic knowledge of fundamental manufacturing concepts is
preferred. Does not require extensive technical knowledge of
- 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 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 , US_MFG Associate, Downstream, Other , Fremont, California
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