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Job Description
About the role:
The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, he/she may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.
How you will contribute:
Prepare media and buffer solutions.
Operate Clean-in-Place (CIP) and Steam-in-Place systems.
Assemble and operate filtration systems.
Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.)
Monitor and record critical process parameters.
Complete all relevant paperwork following GDP/GMP guidelines.
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
Perform sampling using aseptic techniques.
Participate on Continuous Improvement Teams.
Train and mentor other team members.
Write, revise and review pertinent documentation as appropriate.
Troubleshoot process problems and respond to process alarms.
Assist with process/equipment validation and data analysis.
Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
Initiate and/or coordinate other process improvement projects.
May perform other duties as assigned.
What you bring to Takeda:
Requires high school diploma or GED plus 2+ years of experience or associates' degree or higher and 1+ years of related work experience.
Knowledge of cGMP manufacturing.
Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
Must be able to apply quantitative analysis to analyze process performance.
Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills.
Knowledge of basic chemical and biological safety procedures.
Good computer skills, knowledge of Microsoft Word and Excel.
Very good interpersonal skills and be able to work effectively and efficiently in a team environment.
Must have and display the following personal attributes: Integrity, trust, work ethic, sound judgment, intellectual honesty, and conviction.
Important Considerations
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 carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.
Must be able to climb ladders and stairs while wearing special gowning.
May require bending, twisting, reaching overhead, 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, wet environment.
May be working in a loud area that requires hearing protection and other protective equipment to be worn.
Will work around chemicals such as alcohol that may require respiratory protection.
Will handle non-hazardous, hazardous and flammable materials/chemicals.
Must be able to work multiple shifts, including weekends. 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.
May require immunization before performing work within the manufacturing area.
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.
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 - GA - Social Circle - Hwy 278
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 - GA - Social Circle - Hwy 278
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
No
