Manufacturing Tech II

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About the role: This position is responsible for supporting all current and future processes in production in B8 Purification which may include small, mid or large-scale manufacturing, while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. They are 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. They have enough technical and administrative competence to initiate minor revisions to existing documents, to troubleshoot simple existing procedures, and to contribute to continuous improvement initiatives.

They must always promote Takeda’s focus on Patient, Trust, Reputation, and Business.

• 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.
• Interface and Navigate through the Delta
  
  V, Programmable Logic Controller (PLC), and Electronic Batch Management (EBM) systems to effectively respond to process events, changes, and tasks.
• Respond to alarms properly and accurately escalate the issue to supervision/management, and the appropriate support groups when necessary.
• 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.

• High school diploma or GED plus 1+ years of related experience or AA or higher with no prior experience required.
• General working knowledge of related manufacturing techniques and specialties.
• Basic Automation experience using Delta
  
  V, 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.

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…