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Job Description

About the role:

As a Manufacturing Technician I, you will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. You will report to Manufacturing Supervisor.

The hours of this position are 6:00PM-6:00AM, 2-2-3 Rotational schedule; weekend and holiday work.

How you will contribute:

• Troubleshoot and resolve basic process related issues • recognize and escalate deviation
• Execution of critical and routine activities in support of production
• Perform Batch Record, Log Book and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS) , MODA and or other business functions
• Review GMP documentation • Sample preparation and testing
• Identify changes needed to documentation
• Participate in tiered visual management system and support CI initiatives
• Complete required training on time
• Initiating workorders
• Assembly and disassembly of process equipment
• Perform scheduled cleaning of equipment
• Perform standardization of equipment • Support change over activities
• Execution of equipment and process qualifications as well as validation
• Maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self-assessment on development plan
• Accomplishes tasks mainly through direct operation of cGMP activities.
• Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff.
• Evaluate and elevates issues to senior staff.
• Identifies process deviations, troubleshoots issues and identifies process improvements.

What you bring to Takeda:

• Normally requires a high school diploma and 2+ years of experience or an Associate's Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience.
• Biotech Certificate preferred
• May be required to perform as a subject matter expert for equipment and/or systems
• The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
• Possess excellent communication and troubleshooting skills.
• Full awareness of current Good Manufacturing Practices.
• Proficient computer skill
• Basic trouble shooting skills
• Proficient in Aseptic Technique

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 to support production demands.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• May require weekend or holiday off shift support as needed
• Please be aware that this position is considered "Essential Personnel." This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary. To ensure "Essential Personnel" are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event). These details will be provided by management prior to any potential inclement weather situation.
• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force.
• Ability to stand for 6 hours in a production suite.
• Ability to climb ladders and work platforms. Stooping or bending to check or trouble-shoot equipment operations.
• Ability to work around chemicals (alcohols, acids & bases).

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

For Location:

USA - MA - Lexington - BIO OPS

U.S. Hourly Wage Range:

$18.85 - $29.62

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 - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No

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