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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, this role 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. The role 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: - Operate Clean-in-Place (CIP) and Steam-in-Place systems.
- Assemble valve assemblies and filter carts
- Operate general production equipment (such as autoclave, COP washer, etc.)
- Execute Electronic Batch Management (EBM) program to document all activities
- Complete all relevant paperwork following GDP/GMP guidelines.
- Perform routine cleaning of production rooms and equipment to maintain in GMP fashion.
- Perform sampling using aseptic techniques
- Participate on Continuous Improvement Team
- Receive and distribute supplies into production areas as necessary.
- Train and mentor other team members
- Revise and review pertinent documentation as appropriate
- Assist in troubleshooting process problems and responding to alarms
- 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 basic chemical and biological safety procedures.
- Good computer skills, knowledge of Microsoft Word and Excel.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- This position requires shift, weekend and holiday work. Overtime may be required at times.
- The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
- May require immunization before performing work within the manufacturing area.
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:
- 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.
Shift Requirements:- 2-2-3 Rotating Day Shift (6:00 AM - 6:30 PM) Includes weekends, some holidays, and required overtime.
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 e mployee s may be eligible for s hort - t erm 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.
LocationsUSA - GA - Social Circle - Hwy 278
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ExemptNo