Job Description

About the role:

As a Manufacturing Technician I, you will execute all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. You will participate in both departmental projects and any quality working teams which may be applicable.  You will initiate new documents for procedures which are simple in nature and may also make minor revisions to existing documents and will troubleshoot simple existing procedures You will demonstrate procedures as a part of a training session and may schedule department or process activities which could involve coworkers.

How you will contribute:

Prepare media and buffer solutions.
Operate Clean-in-Place (CIP) and Steam-in-Place systems. Assemble and operate filtration systems.
Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
Monitor and record critical process parameters.
Complete all relevant paperwork following GDP/GMP guidelines.
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
Perform sampling using aseptic techniques. Participate on Continuous Improvement Teams.
Receive and distribute supplies into production areas as necessary. Train and mentor other team members.
Revise and review pertinent documentation as appropriate.
Assist in troubleshooting process problems and responding to alarms.
May perform other duties as assigned.

What you bring to Takeda:

TypicallyrequireshighschooldiplomaorGEDplus1+yearsofrelatedexperienceorassociate degree or higher with no prior experiencerequired.

Knowledge of cGMP manufacturing.

Knowledgeofbasiclaboratoryandpharmaceuticalproductionequipmentincludingbut not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.

Proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.

Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

Knowledgeofbasicchemicalandbiologicalsafetyprocedures.

KnowledgeofMicrosoftWordandExcel

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.

Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

May be required to work in a confined area.

Some Clean Room and cool/hot storage conditions.

May require immunization before performing work within the manufacturing area.