Manufacturing Technician

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Responsible for the hands-on execution of production operations in full compliance with cGMP, Environmental Health and Safety (EHS) requirements, and all applicable regulations. Under the direction of the Manufacturing Lead Operator, Supervisor and Manufacturing Lead, this role supports daily manufacturing and departmental initiatives, participates in quality-focused project work, and may lead a small team around specific equipment or act as a delegate for the Lead Operator as needed.

The position applies strong technical knowledge to operate and troubleshooting manual and automated systems, supports technology transfer activities, and contributes to creating, revising, and improving procedures, including developing new or complex procedures when required. The role also provides meaningful exposure to validation and qualification work, partnering closely with engineers and external vendors to help ensure facility and equipment readiness while building technical capability and contributing to the continued advancement of Takeda’s manufacturing operations.

Throughout all activities, the incumbent upholds Takeda’s focus on Patient, Trust, Reputation, and Business.

• Execute day-to-day manufacturing operations in full compliance with safety policies, cGMP/GDP, SOPs, validation protocols, work rules, and applicable company policies/initiatives.
• Perform hands-on manual and automated manufacturing activities, including operating/monitoring process equipment (e.g., centrifuges, filter presses, ultrafiltration/nanofiltration systems, CIP, chromatography and material-handling equipment) and completing associated tasks (e.g., weighing/adding chemicals, transfers/connections, titrations, equipment assembly/disassembly, equipment/room cleaning).
• Complete all required documentation/paperwork accurately and contemporaneously per GDP/GMP, ensuring activities are properly recorded and compliant.
• Partner with Quality and Quality Validation to ensure work is performed correctly, deviations are addressed, and documentation meets requirements.
• Troubleshoot process deviations and equipment/process issues; respond promptly and effectively to alarms; escalate and communicate safety, quality, compliance, and equipment concerns to lead operator/supervisor as needed.
• Coordinate with Maintenance/Engineering/Metrology to resolve equipment, utilities, and systems issues and to support preventive and corrective maintenance execution.
• Coordinate with Schedulers and RTMS to ensure project/manufacturing steps are executed as planned, including making RTMS updates/adjustments when required.
• Receive, stage, request/order, and distribute materials, parts, supplies, and tools to support production activities.
• Remove, segregate, and properly handle manufacturing and hazardous waste in accordance with established procedures.
• Perform sanitization, bio-cleaning, and facility/area cleaning activities; coordinate with ISS as needed; ensure cleaning activities are completed and documented.
• Collaborate with leadership, engineers, PETs, and cross-functional project team members to ensure successful execution of manufacturing/validation/project activities.
• Participate in project meetings, daily huddles, and other required communications to maintain alignment and execution readiness.
• Support operational excellence/continuous improvement by developing/refining micro-steps, using CI tools, and initiating/coordinating process improvement projects.
• Support team capability by assisting the lead operator (including leading small teams around equipment), acting as delegate when needed, and training/mentoring manufacturing-floor team members.
• Contribute to the creation, revision, and review of manufacturing-related documents (e.g., SOPs, batch records, protocols) as…