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Job Description

About the role:

This position 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. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the manufacturing lead operator and the overall direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. Activities include manual tasks and operation of automated equipment. He/She has sufficient technical and administrative competence to initiate minor revisions to existing documents, to troubleshoot simple existing procedures, and to contribute to continuous improvement initiatives. He/She must always promote Takeda’s focus on Patient, Trust, Reputation, and Business.

How you will contribute:

Essential Duties and Responsibilities

• Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
• Support all local manufacturing operations.
• Complete relevant paperwork following GDP/GMP guidelines.
• Perform hands-on execution of manual and automated manufacturing operations. Equipment includes but is not limited to: Centrifuges, Filter Presses, Ultrafiltration systems, CIP/COP, Nanofiltration Skids, Chromatography Columns 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 minor process problems and respond to process alarms.
• Communicate issues related to safety, quality, compliance and equipment to the manufacturing lead operator and supervisor. 
• Participate in the training of team members on the manufacturing floor.
• Participate in the revision and review of pertinent documentation as appropriate.
• Participate in Safety and Continuous Improvement Teams.

What you bring to Takeda:

Qualifications

• Must be proficient in written and oral English.

• General working knowledge of related manufacturing techniques and specialties.
• Basic 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 good 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.
• 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.

Education and/or experience

• Required: High school diploma or GED plus 1+ years of related experience or AA or higher with no prior experience required

Physical Demands

• 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.

Working Environment

• 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 around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.
• Will work in a cold, wet environment.
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required. (only for non-exempt positions)
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.

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

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.

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.

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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.

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