Manufacturing Lead

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Job Description

About the role:

The Manufacturing Operations V role is responsible for managing and performing work associated with converting raw materials and components into finished goods. This includes general production manufacturing work, assembling finished components, process manufacturing batches, setting up and operating machine tools, surface finishing, and packaging materials or finished goods. This role supports Takeda's mission by ensuring high-quality production processes and adherence to safety and regulatory standards.
 

How you will contribute:

• Supports all local manufacturing operations.
• Assist supervisor in organizing, scheduling and directing other team members.
• Conduct shift change meeting as needed in lieu of shift supervisor.
• Troubleshoot process problems and respond to process alarms. Main troubleshooting/response person.
• Operate general production equipment for the assigned area.
• Prepare media and buffer solutions.
• Main interface with other departments to resolve issues related to equipment, process, and compliance, including maintenance, metrology, and validation.
• Complete relevant paperwork following GDP/GMP guidelines.
• Write, revise and review pertinent documentation as appropriate.
• Participate on Continuous Improvement Teams and may serve in a leadership role.
• Represent the department in cross functional teams as necessary.
• Initiate and/or coordinate other process improvement projects.
• Train and mentor other team members.
• Assist with process/equipment validation and data analysis.
• Assign other project work and/or involvement in teams to team members.
• Perform removal of hazardous waste.

What you bring to Takeda:

• Requires high school diploma or GED plus 6+ years of experience or associates’ degree or higher with 4+ years related work experience.
• In-depth process knowledge of related manufacturing techniques and specialties.
• Must have good written and verbal communication skills and understanding of cGMP regulations. Good procedural writing skills.
• Must be able to read and follow detailed written instructions.
• Must be able to apply quantitative analysis to analyze process performance.
• Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
• Must have demonstrated interpersonal and leadership skills and be able to work effectively and efficiently in a team environment.
• Knowledge of basic chemical and biological safety procedures.
• Must have strong computer skills.

Important Consideration

• 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.
• Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.
• May be required to work