US_MFG Associate/Sr Associate, Downstream
Company: Boehringer Ingelheim
Location: Fremont
Posted on: August 4, 2022
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Job Description:
Job Description Description:\n \n Description\: \n\n \n\n
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.
\n\n \n\n 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 \n\n \n\n Duties & Responsibilities\: \n\n \n\t Executes,
with oversight of qualified staff, complex unit operations
including but not limited to chromatography operations, tangential
flow filtration, various filtration methods, and process
monitoring. \n\t \n Executes independently with adequate training
fundamental operations\: \n\t \n\t\t CIP/SIP of tanks, transfer
lines, and process equipment. \n\t\t Buffer preparation and
transfer into tanks and disposables. \n\t\t Performs In process
testing for samples e.g. spectrophotometry, pH, conductivity, and
maintenance of analytical equipment. \n\t \n\t \n\t This may
include parts cleaning and weigh and dispense. \n\t Performs
internal support duties including stocking consumables/materials,
updating controlled SOP binders, appropriately discarding expired
reagents, recognizing and reporting process and equipment
anomalies. \n\t Documents work according to cGMP and cGDP. \n\t
Adheres to established regulations and follows cGMP established by
site. \n\t Reports abnormalities and deviations in a timely and
accurate manner. \n\t Adheres to safety standards and identifies
unsafe situations / habits and escalates appropriately. \n\t
Maintains production areas according to predefined standards (5s).
\n\t Maintains own training within compliance and trains other
technicians and associates on operations upon completion of trainer
qualification. \n\t Contributes to Quality activities as
investigations and area walk-throughs. \n \n\n Requirements\: \n\n
\n\t High school degree plus minimum one (1) year work experience
in GMP regulated industry \n\t Associates/Bachelor ---s degree from
an accredited institution or biotechnology vocational training
preferred. \n\t One (1) or more years of experience in cGMP
regulated industry. \n\t Ability to concentrate on detail oriented
work in a complex technical setup with a Quality and Right the
first time mindset. \n\t Strong written and verbal communication
skills. \n\t Ability to work with computer-based systems and
ideally experience with process control systems (e.g. Delta V) and
manufacturing execution systems (MES). \n\t Ability to read and
understand SOPs and work instructions and document work in a
written format applying cGMP standards. \n\t Ability to work as
part of a high performing team and collaborate effectively with
staff. \n\t Basic knowledge of fundamental manufacturing concepts
is preferred. Does not require extensive technical knowledge of
manufacturing operations. \n\t Working in a highly regulated
environment following all applicable BI and BI Fremont SOPs, OCPs
and BGSs for cGMP, EHS and Compliance policies. \n\t Required to
work according to given schedules in a 24/7 shift structure and
flexibility to adapt working schedule upon prior given notice. \n
\n\n SR MFG Associate \n\n Requirements\: \n\n \n\t High school
degree plus minimum two (2) year---s work experience in GMP
regulated industry \n\t Associates/Bachelor ---s degree from an
accredited institution or biotechnology vocational training
preferred. \n\t 2 or more years of experience in cGMP regulated
industry. \n\t Ability to concentrate on detail oriented work in a
complex technical setup with a Quality and Right the first time
mindset. \n\t Strong written and verbal communication skills. \n\t
Ability to work with computer-based systems and ideally experience
with process control systems (e.g. Delta V) and manufacturing
execution systems (MES). \n\t Ability to read and understand SOPs
and work instructions and document work in a written format
applying cGMP standards. \n\t Ability to work as part of a high
performing team and collaborate effectively with staff. \n\t
Requires moderate to high technical knowledge of biologics
manufacturing operations. \n\t Working in a highly regulated
environment following all applicable BI and BI Fremont SOPs, OCPs
and BGSs for cGMP, EHS and Compliance policies. \n\t Required to
work according to given schedules in a 24/7 shift structure and
flexibility to adapt working schedule upon prior given notice. \n
\n\n Eligibility Requirements\: \n\n \n\n \n\t \n Must be legally
authorized to work in the United States without restriction. \n
\n\t \n Must be willing to take a drug test and post-offer physical
(if required) \n \n\t \n Must be 18 years of age or older \n \n
\n\n \n\n \n\n Who We Are\: \n\n \n\n 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. \n \n\n Want to learn more? Visit boehringer-ingelheim.com
and join us in our effort to make more health. \n \n\n 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. \n\n
Keywords: Boehringer Ingelheim, Fremont , US_MFG Associate/Sr Associate, Downstream, Other , Fremont, California
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