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Job Description
About the role:
Responsible for the hands-on execution of production operations in full compliance with cGMP, Environmental Health and Safety (EHS) requirements, and all applicable regulations. Under the direction of the Manufacturing Lead Operator, Supervisor and Manufacturing Lead, this role supports daily manufacturing and departmental initiatives, participates in quality-focused project work, and may lead a small team around specific equipment or act as a delegate for the Lead Operator as needed. The position applies strong technical knowledge to operate and troubleshooting manual and automated systems, supports technology transfer activities, and contributes to creating, revising, and improving procedures, including developing new or complex procedures when required. The role also provides meaningful exposure to validation and qualification work, partnering closely with engineers and external vendors to help ensure facility and equipment readiness while building technical capability and contributing to the continued advancement of Takeda's manufacturing operations. Throughout all activities, the incumbent upholds Takeda's focus on Patient, Trust, Reputation, and Business.
How you will contribute:
Execute day-to-day manufacturing operations in full compliance with safety policies, cGMP/GDP, SOPs, validation protocols, work rules, and applicable company policies/initiatives.
Perform hands-on manual and automated manufacturing activities, including operating/monitoring process equipment (e.g., centrifuges, filter presses, ultrafiltration/nanofiltration systems, CIP, chromatography and material-handling equipment) and completing associated tasks (e.g., weighing/adding chemicals, transfers/connections, titrations, equipment assembly/disassembly, equipment/room cleaning).
Complete all required documentation/paperwork accurately and contemporaneously per GDP/GMP, ensuring activities are properly recorded and compliant.
Partner with Quality and Quality Validation to ensure work is performed correctly, deviations are addressed, and documentation meets requirements.
Troubleshoot process deviations and equipment/process issues; respond promptly and effectively to alarms; escalate and communicate safety, quality, compliance, and equipment concerns to lead operator/supervisor as needed.
Coordinate with Maintenance/Engineering/Metrology to resolve equipment, utilities, and systems issues and to support preventive and corrective maintenance execution.
Coordinate with Schedulers and RTMS to ensure project/manufacturing steps are executed as planned, including making RTMS updates/adjustments when required.
Receive, stage, request/order, and distribute materials, parts, supplies, and tools to support production activities.
Remove, segregate, and properly handle manufacturing and hazardous waste in accordance with established procedures.
Perform sanitization, bio-cleaning, and facility/area cleaning activities; coordinate with ISS as needed; ensure cleaning activities are completed and documented.
Collaborate with leadership, engineers, PETs, and cross-functional project team members to ensure successful execution of manufacturing/validation/project activities.
Participate in project meetings, daily huddles, and other required communications to maintain alignment and execution readiness.
Support operational excellence/continuous improvement by developing/refining micro-steps, using CI tools, and initiating/coordinating process improvement projects.
Support team capability by assisting the lead operator (including leading small teams around equipment), acting as delegate when needed, and training/mentoring manufacturing-floor team members.
Contribute to the creation, revision, and review of manufacturing-related documents (e.g., SOPs, batch records, protocols) as required.
Maintain flexibility to work extended hours (up to 12 hours per day) and/or alternative shifts to support operations, validation, and project needs.
Perform other duties as assigned.
What you bring to Takeda:
High school diploma or GED 2+ years of experience or AA or higher and 1+ years of relatedwork experience.
Advanced process knowledge of related manufacturing techniques and specialties.
Thorough 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 understanding of cGMP regulations in a pharmaceutical manufacturing environment.
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.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
Knowledge of basic chemical and biological safety procedures.
Good computer skills.
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:
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.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
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 #LI-MA1
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 - CA - Los Angeles
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 - CA - Los Angeles
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
No
