Manufacturing Tech IV
Company: Feed 8
Location: Anaheim
Posted on: May 13, 2022
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Job Description:
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to the best of my knowledge.
Job Description
About 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 will contribute :
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. 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 necessary 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 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. 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 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 JD Edwards Receive and
distribute supplied into the production area as needed. May perform
removal of hazardous waste. In-depth process knowledge of related
manufacturing techniques and specialties. 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) guidance
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. 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. 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 gowning. 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 body 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
required. May be required to work in a confined area. Some Clean
Room and cool/hot storage conditions.
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
#GMSGQ #ZR1
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 - CA - Los Angeles
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Feed 8, Anaheim , Manufacturing Tech IV, Other , Anaheim, California
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