Manufacturing Tech IV-Centrifuge SME
Company: Takeda
Location: Los Angeles
Posted on: January 28, 2023
Job Description:
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Job Description
About the Role:
The Manufacturing Tech IV is responsible for aiding in executing
processes in production while strictly adhering to cGMP,
environmental health and safety guidelines and any other related
regulations which could apply. This person is expected to fully
participate in both departmental projects and any quality working
teams which may be applicable. Under the overall direction of the
Supervisor and Manufacturing Lead, this position shall aid in the
leadership and execution of activities in the production area. When
the Manufacturing Lead is absent, the Manufacturing Tech IV will
act as their delegate. They will utilize DMAIC problem solving
skills, execute Preventive Maintenance and be responsible for the
assembly and disassembly of the centrifuges, Mechanical
Troubleshooting and repair, etc. In addition to the manufacturing
responsibilities described in this job description. They may be
asked to problem solve in other functional areas. They will fully
understand the regulations and may make recommendations according
to their interpretations. They will have sufficient technical and
administrative knowledge to perform complex troubleshooting tasks
on manual and automated equipment and assist during the transfer of
new processes/methodologies into the manufacturing area.
Manufacturing Tech IVs are expected to set the example for other
Takeda employees as their team members observe the behavior of
their leadership and interpret that behavior as acceptable. They
must always promote Takeda's focus on Patient, Trust, Reputation,
and Business.
How you will contribute:
- Responsible for the assembly and disassembly of the centrifuges
in the manufacturing area
- Attend weekly/biweekly centrifuge meetings
- Expected to work with engineering and maintenance regarding
ideas for improvement as well as corrective work.
- Responsible for executing all aspects of the Centrifuge
Troubleshooting Guidelines.
- Responsible for maximizing the life of centrifuge bowls,
components, tools, and ancillary support equipment thru operator
care principles.
- Responsible for overseeing and assisting with on-the-job
training of other Manufacturing Techs on SOPs for centrifuge
assembly, disassembly, and operations. Follow safety rules, SOPs,
cGMP, work rules and other company policies and
initiatives.Complete relevant paperwork following GDP/GMP
guidelines.Perform hands-on execution of manual and automated
manufacturing operations. Equipment may include: Centrifuges,
Filter Presses, Ultrafiltration systems, CIP/COP, Nano-filtration
Skids, Chromatography Columns and material handling devices. Manual
activities include weighing and addition of chemicals, paste
suspension, equipment cleaning, room cleaning, equipment
assembly/disassembly, transfer panel connections, titrations and
other activities.Receive and distribute supplies into the
production area as necessary.Troubleshoot process problems and
respond to process alarms.
- May assist Manufacturing Lead and Supervisor with managing
manufacturing personnel to resolve and communicate issues related
to safety, quality, compliance and process to the supervisor.
- May serve as main interface with other departments including
maintenance, metrology, engineering and validation.
- May assist Supervisor/Manufacturing Lead in organizing,
scheduling and directing other team members.
- Participate in the training, coaching and mentoring of team
members on the manufacturing floor.
- Write, revise and review manufacturing related documents as
appropriate.
- Participate in Safety and Continuous Improvement Teams and may
serve in a leadership role.
- Initiate and/or coordinate other process improvement
projects.
- Drive performance of team members by promoting a positive work
environment emphasizing respect, responsiveness, and results.
- May create and update daily production schedules. May interface
with production scheduling tools DeltaV, Manufacturing Execution
Systems and other supporting tools.
- May perform preventive maintenance of critical manufacturing
equipment
- Write and/or revise preventive procedures as needed
- Provide a moderate level of troubleshooting, diagnostic, and
repair of critical manufacturing equipment
- May execute sanitization of department specific critical
systems
- May generate and execute Maintenance Work Orders using
JDEdwards
- Perform removal of hazardous waste.
- Must pass the centrifuge written proficiency test and pass the
hands-on assembly/disassembly test Recertification may be
required.
- In-depth process knowledge of related manufacturing techniques
and specialties.
- Advanced automation experience using DeltaV, Electronic Batch
Management, PLC, etc.
- Familiarity with pharmaceutical production equipment including
but not limited to centrifuges, filtration systems and CIP/SIP
(Clean in Place/Steam in Place).
- Experience operating material handling equipment such as pallet
jacks and forklifts.
- Must have strong communication skills (both verbal and written)
and a robust understanding of cGMPs and other regulatory guidelines
applicable to the medical/pharmaceutical industry.
- Must be able to read and follow detailed written
procedures.
- Must be able to apply quantitative analysis to analyze process
performance.
- Must be proficient in a variety of mathematical disciplines and
be able to work with both the metric and USA standards of
measurement.
- Must have demonstrated interpersonal and leadership skills and
be able to lead a team effectively.
- Knowledge of basic chemical and biological safety
procedures.
- Must have good computer skills including knowledge of Microsoft
Office applications. Experience with applications such as LIMS and
JD Edwards may be required.
- Experience in DeltaV, Manufacturing Execution Systems,
scheduling software or similar systems.
- Must be able to complete tasks with minimal supervision,
prioritize multiple tasks, and manage time effectively.
- Basic knowledge of instrumentation and mechanical such as
controllers, indictors, control valves, PLC, analyzers, sensors,
pumps, etc.
What you bring to Takeda:
- Requires high school diploma or GED with 4+ years related work
experience, or AA or higher with 2+ years related work experience.
Mechanical, electrical, instrumentation, or control systems repair
experience preferred for mechanical special skills role.
- Must be able to lift, push, pull and carry up to 50 lbs.
- Must be able to stand for extended periods of time throughout
the duration of an 8- or 12-hour shift.
- Must be able to climb ladders and stairs while wearing special
gowning.
- May require bending, twisting, reaching, and/or squatting
motions to perform certain tasks.
- In general, the position requires a combination of sedentary
work and walking around observing conditions in the facility
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement.
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.
Empowering our people to shine:
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.
Location and Salary Information: This post excludes CO
applicants
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 .
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Keywords: Takeda, Los Angeles , Manufacturing Tech IV-Centrifuge SME, Other , Los Angeles, California
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