Manufacturing Technician IV at Baxalta U.S., Inc. in Los Angeles, California

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 JD Edwards


• Perform removal of hazardous waste.

What you bring to Takeda:

• 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.


• 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.


• 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 around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.


• Will work in a cold, wet environment.


• Must be able to work multiple shifts, including weekends.


• 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