By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (https://jobs.takeda.com/privacynotice) and Terms of Use (https://www.takeda.com/terms-and-conditions/) . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
The Manufacturing Lead Operator is responsible for executing processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the overall direction of the supervisor, this person must aid in establishing daily shift priorities, and then skillfully communicate and delegate tasks in order to safely accomplish those priorities. They are expected to exercise proper judgement with regards to Safety, Quality, and Production decisions. They must be able to apply their subject matter expertise and their understanding of the capabilities and performance of their team members in order to quickly assess critical issues. They must be able to effectively escalate all relevant information and be prepared to recommend appropriate actions. They are expected to be able to communicate all critical information to their respective teams as well as be able to relay the appropriate shift-to-shift updates through all applicable communication tools and at shift handoffs. In addition to being fully accountable in production processes, this person may help problem solve in other functional areas. They are expected to fully participate in both departmental projects and quality working teams. The incumbent shall act as a delegate to the supervisor and may conduct departmental activities in their absence. They fully understand the regulations and may make recommendations according to their interpretations. They have a high level of technical and administrative knowledge to perform complex troubleshooting tasks on manual and automated equipment, and they may assist during the transfer of new processes/methodologies into the manufacturing area. Manufacturing Lead Operators are expected to serve as a mentor and set the example for all team members since their team will interpret that behavior as acceptable.
How you will contribute:
Follow all 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, Tangential Flow Filtration and Nanofiltration systems, CIP/COP, Chromatography 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.
Perform removal of hazardous waste.
Troubleshoot process problems and respond to process alarms.
Act as the primary manufacturing personnel to resolve and communicate issues related to safety, quality, compliance and process to the supervisor. Main interface with other departments including maintenance, metrology, engineering and validation.
Assist supervisor in organizing, scheduling, and directing other team members.
May act as a delegate to the supervisor in their absence.
Participate in the training and mentoring of team members on the manufacturing floor.
Write, revise, and review manufacturing related documents as appropriate.
Initiate and/or coordinate other process improvement projects.
Drive performance of team members by promoting a positive work environment emphasizing Patient, Trust, Reputation, and Business.
What you bring to Takeda:
High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience.
Must have demonstrated interpersonal and leadership skills and be able to lead a team effectively.
Demonstrated record of exercising proper judgment with regards to Safety, Quality, Compliance, and Production decisions.
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).
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.
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 preferred.
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
Facial hair must be removed if required to wear respirator.
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.
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:
$27.60 - $43.37
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
