Manufacturing Tech IV
Company: Takeda Pharmaceutical
Posted on: May 10, 2022
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information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAbout the role: This position is
responsible for supporting all current and future processes in
production in B8 Purification which may include small, mid or
large-scale manufacturing, while strictly adhering to cGMP,
environmental health and safety guidelines and any other related
regulations which could apply. They are 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 and is will be a subject matter expert. They
fully understand the regulations and may make recommendations
according to their interpretations. They have enough technical
knowledge to perform complex troubleshooting tasks on manual and
automated equipment and assists 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 his/her 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
- 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
- Train to become proficient in multiple product lines and
support various areas within the manufacturing suites.
- Interface and Navigate through the DeltaV, Programmable Logic
Controller (PLC), and Electronic Batch Management (EBM) systems to
effectively respond to process events, changes, and tasks
- Respond to alarms properly and accurately escalate the issue to
supervision/management, and the appropriate support groups when
- Coordinate manufacturing process related issues with Quality
Operations prior to intervening in the system
- 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
- Participate in Safety and Continuous Improvement Teams and may
serve in a leadership role.
- Initiate and/or coordinate other process improvement
- Drive performance of team members by promoting a positive work
environment emphasizing respect, responsiveness, and results.
- Will collaborate with various support groups, such as
Manufacturing Support, and interface with production scheduling
tools, DeltaV, Manufacturing Execution Systems and others.
- May perform preventive maintenance of critical manufacturing
- 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
- May generate and execute Maintenance Work Orders using JD
- Receive and distribute supplied into the production area as
- May perform removal of hazardous waste.
- In-depth process knowledge of related manufacturing techniques
- Advanced automation experience using DeltaV, Electronic Batch
Management, PLC, etc.
- Ability to correct GDP type errors in the electronic systems
(DeltaV, EBM, PLC, etc.)
- Ability to trend data in DeltaV and EBM systems for
investigations and/or process deviations
- Proficient in DeltaV and EBM to a level that aligns with area
of responsibility and standard operating procedure (SOP)
- 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
- Must be able to apply quantitative analysis to analyze process
- Must be proficient in a variety of mathematical disciplines and
be able to work with both the metric and USA standards of
- Must have demonstrated interpersonal and leadership skills and
be able to lead a team effectively.
- Knowledge of basic chemical and biological safety
- Must have good computer skills including knowledge of Microsoft
Office applications. Experience with applications such as LIMS and
JD Edwards may be required.
- 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
- Must be able to lift, push, pull and carry up to 50 lbs.
- In general, the position requires a combination of sedentary
work and walking around observing conditions in the facility.
- 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
- May require bending, twisting, reaching, and/or squatting
motions to perform certain tasks.
- Must be able to work in controlled environments requiring
special gowning. Will be required to follow gowning requirements
and wear protective clothing over the head, face, hands, feet and
- No make-up, jewelry, contact lenses, nail polish or artificial
fingernails may be worn in the manufacturing environment.
- Will work in a cold and/or wet environment.
- Must be able to work multiple shifts, including weekends.
- Non-Exempt Roles only: Must be able to work overtime as
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.What Takeda can
- 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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursementMore 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#GMSGQ #ZR1EEO StatementTakeda 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.LocationsUSA - CA - Los
AngelesWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
Keywords: Takeda Pharmaceutical, Anaheim , Manufacturing Tech IV, Other , Anaheim, California
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