Mfg Associate/Associate, Pharmaceutical Manu
Company: Boehringer Ingelheim
Location: Fremont
Posted on: June 22, 2022
Job Description:
Description:Description\:This position is responsible for
assisting the Sr. Associate and Master Associate in performing
material handler duties, cleaning, visual inspection and filling
responsibilities in designated manufacturing area. -Specific to the
Sterile Filling area, this includes, but is not limited to\:
- Assists in the setup of filling room and Isolator
- Movement of product, components and equipment within the
aseptic processing area
- Transfers product, components and equipment within the CNC,
Class C and Class D processing areas.
- Assists with the cleaning of parts and equipment
- Assists with minor equipment repairs/adjustments
- Assists in the identification & correction of problems to
prevent down-time
- Communication and hand-off to relief personnel during shift
change as appropriate
- Assists in the filling operation -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 the Sr. Associate and / or Master Associate with
Isolator and equipment set up. - This assistance includes tasks
such as gathering tools, machine parts, and documents required for
such activities. - Retrieves components and equipment from aseptic
storage.
- Assists the Sr. and Master Associate with real-time
identification and correction of problems. - Problems may include,
but are not limited to mechanical issues, component issues.
- Performs all work in accordance with Company Policies and
Procedures. - All work is documented in controlled documents (batch
records, logbooks or SOP attachments) in accordance with SOP. - All
activities are to be documented in the batch record. - All events
are to be recorded in the batch record and brought to the attention
of the production supervisor for further action.
- Assists with Isolator and room cleaning in production areas. -
Will transfer rubbish to the transfer zones and may empty transfer
zones of rubbish when required. - This includes removal of
equipment, room sanitization and disposal of waste according to
established safety requirements.
- Responsible for following controlled documents to ensure that
the equipment identified for operations - are used and documented.
- This includes verification of equipment calibration. - Completes
log books, as required.
- Responsible for performing filling operations and assisting in
visual inspection operations.
- Ensures components, materials and supplies are stocked prior to
the start of the filling operations.Requirements\:
- Bachelors' degree, preferably in a science or engineering
field.
- In lieu of a Bachelor's degree, will consider a minimum of
three years closely related experience in a GMP or clean room
assembly environment with an Associates Degree or six (6) years
closely related experience in a GMP or clean room assembly
environment with a High School Diploma or equivalent
- Demonstrated ability to be organized and work well in small
work groups.
- Must be able to assist in trouble shooting activities and
repairs to production equipment under the guidance of more
experienced technicians.
- Demonstrated mathematical skills, including the ability to
perform addition, subtraction, multiplication, division, and
conversions.
- Detail oriented. - Demonstrated ability to read, comprehend,
and follow written instructions.
- Demonstrated written and verbal communication skills are
required.
- Must be able to work in a team environment.
- Experiences in related GMP environment within
biotechnology/pharmaceutical industry strongly preferred
- Must be able to learn and perform basic computer operations
such as MS Office and Outlook and other computer based
software
- Physical Demands / Surroundings - Requires physical activity
such as almost constant standing, walking, eyestrain, working with
hands inside an Isolator, etc. Works regularly under desirable
conditions with some moderately disagreeable conditions in the
manufacturing setting.
- Visual Demands - Position requires constant use of computer
terminals and routine / repetitive work.
- Temperaments/Mental Requirements - The position requires
concentration as errors might cause minor to moderate delays,
confusion, or expense to correct. - The position has some contact
with other departments and the associate must be able to discuss
issues and ideas with an open mind and even temper.
- Level of Proficiency - Entry level in subject matter
- Attendance / Schedule- The schedule is dependent on the shift
for which the associate is hired. - Attendance requirements are
based on general attendance policies.
- To remain in this position, employees\:
- Must obtain & maintain qualifications, as required, to perform
the assigned work. -
- Must understand, will be held accountable for and must adhere
to all SOPs, company Policies and Procedures
- Must adhere to proper technique, proper documentation
practices, and all other aspects of the cGMP's
- Must maintain all training requirements and regularly checks
the LOS training system in order to complete all required training
on time. -MFG TECH REQUIREMENTS\:Requirements\:
- 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
industry.
- Ability to concentrate on detail oriented work in a complex
technical setup with a Quality and Right the first time
mindset.
- 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
manufacturing operations.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.
Keywords: Boehringer Ingelheim, Fremont , Mfg Associate/Associate, Pharmaceutical Manu, Healthcare , Fremont, California
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