About the role:
You will follow all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, you may rewrite complex procedures or initiate new procedures as applicable. You will have enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. You will have technical and administrative competence to organize and lead production activities, including demonstrating leadership in cGMP compliance, and environmental health and safety skills. You will report to Manufacturing Supervisor.
The hours of this position are 2 PM - 10:30 PM Monday - Friday; weekend and holiday work. Overtime may be required.
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)
- Complete 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 Teams
- Receive and distribute supplies into production areas.
- Mentor other team members
- Revise and review important documentation
- Help troubleshoot process problems and responding to alarms
- Knowledge of cGMP manufacturing
- Knowledge of basic laboratory and pharmaceutical production equipment including: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
- You must be proficient in different mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Will read and follow detailed written instructions.
- Knowledge of basic chemical and biological safety procedures.
- Knowledge of Microsoft Word and Excel.
- Can work in a team environment.
What you bring to Takeda:
High school diploma or GED with 2+ years of experience or AA or higher and 1+ years of related work experience and demonstrated knowledge of scientific principles.
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
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 will:
- 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 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.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Must be able to stand for extended periods of time over an entire 8 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.
- May work in a confined 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.
This posting excludes Colorado applicants.
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.
USA - GA - Social Circle - Hwy 278