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Job Description
About the role : The
role
is responsible
for
executing all
processes
in
production
while
strictly adhering
to
cGMP,
environmental
health
and
safety
guidelines and any
other related
regulations
which could apply.
In
addition
to
making
routine
revisions
to
documents,
you
may
rewrite complex
procedures
or initiate
new procedures
as applicable.
The
incumbent
has
enough
applied
technical
knowledge
to
perform
complex trouble
shooting
tasks
and
may
even
assist
during
t h
transfer
of
new
technologies into
manufacturing. You have
sufficient technical
and administrative
competence
to
organize
and
lead production activities, including demonstrating leadership in
state-of-the-art
cGMP
compliance,
and
environmental
health
and
safety
skills.
How you will contribute :
Prepare
media
and
buffer
solutions.
Operate
Clean-in-Place
(CIP)
and
Steam-in-Place
systems.
Assemble
and
operate
filtration
systems.
Operate
general
production
equipment
(such
as pH
and
conductivity
meters,
autoclave,
portable
mixers, etc.)
Monitor
and
record
critical
process
parameters.
Complete all
relevant
paperwork
following
GDP / GMP
guidelines
Perform
routine maintenance
and
cleaning of
production
equipment
to
maintain
in GMP
fashion.
Perform
sampling using
aseptic
techniques.
Participate on
Continuous
Improvement
Teams.
Train
and
mentor other team members.
Write,
revise
and
review
pertinent
documentation as
appropriate.
Troubleshoot
process
problems
and
respond
to
process
alarms.
Assist
with
process / equipment
validation
and
data analysis.
Work with other
groups
such as
maintenance / metrology
to
ensure
preventative
maintenance is
done.
Initiate and / or coordinate other process
improvement
projects.
May
perform
other duties as assigned.
Knowledge
of cGMP manufacturing.
Knowledge
of basic
laboratory
and
pharmaceutical
production
equipment
including
but not
limited to : autoclaves,
process
tanks,
incubators,
analytical
equipment
and
CIP / SIP
systems.
Must be able
to
apply
quantitative
analysis
to
analyze
process
performance.
Incumbent
must be
proficient
in a
variety
of mathematical
disciplines
and
be able
to
work
with both the metric
and
USA
standards
of
measurement.
Must be able
to
read
and
follow
detailed written instructions
and
have
good
verbal / written
communication skills.
Good
procedural
writing
skills.
Knowledge
of basic chemical
and
biological
safety
procedures.
Good
computer skills,
knowledge
of Microsoft Word
and
Excel.
Very
good
interpersonal
skills
and
be able
to
work
effectively
and
efficiently in a team
environment.
Must
have
and
display the
following
personal
attributes : Integrity,
trust,
work
ethic,
sound judgment, intellectual honesty, and conviction.
Responsible
to
execute
material
transfers
that
include
non-hazardous,
hazardous
and flammable
chemicals
to
support
manufacturing
schedule
adherence.
Maintain a
visual
replenishment
program
of materials using lean
manufacturing
processes / tools.
Maintain
records
of materials in
inventory
and
on
order.
Compile
inventory
records
as
needed.
Reconcile discrepancies in
inventories.
Compile
information
on receipt
and
transfer
of materials.
Resolve
questions
and
problems
and
refers
only most
complex
issues
to
higher
levels.
Contribute
to
a culture of safety first in
compliance
with
Environmental,
Health,
and
Safety
(EHS).
Understand
and
follow
Job
Hazard
Analysis
(JHA)
packets.
Must
have
experience with
inventory
management.
Experience in
handling
pallet-jacks,
pallet
trucks,
and
forklifts
are
a plus.
What you bring to Takeda :
Typically requires a high school diploma or GED plus 2+ years of experience or associates’ degree or higher and 1+ years related work experience.
Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may :
Must be able to carry up to 25 lbs., lift up to 50 lbs., and push / pull >
100 lbs. (with the assistance of material handling equipment).
Must be able to stand for extended periods of time over an entire 8 or 12-hour
shift.
Must be able to climb ladders and stairs while wearing special
gowning.
May require bending, twisting, reaching overhead, and / or squatting motions to perform certain tasks.
May be required to work in a confined
area.
Some Clean Room and cool / hot storage
conditions.
May require immunization before performing work within the manufacturing
area.
May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Will need to remove all make-up, jewelry, contact lenses, nail polish and / or artificial fingernails while in the manufacturing environment.
May work in a cold, hot or wet environment.
May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Will
handle
non-hazardous,
hazardous
and
flammable
materials / chemicals.
May
require
immunization
before
performing
work
within the
manufacturing
area.
Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.
More about us :
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ
#ZR1
Takeda Compensation and Benefits Summary
We understand compensation is
an important factor
as you consider the next step in your career. We are committed to
equitable
pay for all employees, and we strive to be more transparent with our pay practices.
For Location :
USA - GA - Social Circle - Hwy 278
U.S. Hourly Wage Range :
$18.85 - $29.62
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - GA - Social Circle - Hwy 278
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
No
Manufacturing Technician Ii • Social Circle, Georgia, United States