Manufacturing Tech II

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Job Description

About the Role:

As a manufacturing tech II, you will complete all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. You will 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, you will manage the hands-on execution of all activities in the production area.

Activities include manual tasks and operation of automated equipment. You will always promote Takeda's focus on Patient, Trust, Reputation, and Business.

How You Will Contribute

• Follow all safety rules, SOPs, cGMP, work rules and other company policies and programs.
• Support all local manufacturing operations.
• Complete relevant paperwork following GDP/GMP guidelines.
• Working in a team environment, perform hands-on execution of manual and automated manufacturing operations. Equipment includes:
  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.
• Receive and distribute supplies into the production area.
• Perform removal of hazardous waste per safety guidelines.
• 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.
• Help train team members on the manufacturing floor.
• Participate in the revision and review of important documentation.
• Participate in Safety and Continuous Improvement Teams.
• May perform other duties as assigned.

• 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 as well as computers. Familiarity with pharmaceutical production equipment including centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place). Knowledge of basic chemical and biological safety procedures.
• Basic Automation experience using Delta
  
  V, Electronic Batch Management, PLC, etc.
• Proficient in English (both verbal and written) and understanding of cGMP regulations in a pharmaceutical manufacturing environment.
• Can read and follow detailed written procedures. Proficient in different mathematical disciplines and be able to work with both the metric and USA standards of measurement.

• 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.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be able to lift, push, pull and carry up to 50 lbs. with a work partner.
• Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift.
• Must be able to climb ladders and stairs while wearing special gowning.
• May require…