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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 Person