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The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the overall direction of the supervisor, this position shall be
responsible for the hands - on execution of all activities in the production area. In addition to being fully accountable and involv ed in all production processes, he/she may problem so lve in other
functional areas. The incumbent acts as a delegate to the supervisor and may conduct departmenta l activities in their absence. He/She fully understands the regulations and may make recommendations accor ding to their interpretations. He/She is responsible for the successful transfer of new processes/methodologies into the manufacturing area.
Supports all local manufacturing operations.
Assists supervisor in organizing scheduling and directing other team members.
Conduct shift change 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.
Performed removal of hazardous waste.
Responsible to execute material transfers that include non-hazardous, hazardous and flammable chemicals to support manufacturing schedule adherence.
Maintain a visual replenishment program of materials using lean manufacturing process/tools.
Maintain records of materials in inventory and on order.
Compile inventory records as needed.
Reconcile discrepancies in inventories.
Compile information on receipt and transfer of materials.
Resolve questions and problems and refers only most complex issues to higher levels.
Contribute to a culture of safety first in compliance with Environmental, Helth, and Safety (EHS). Understand and follow Job hazard Analysis (JHA) packets.
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 unde rstanding 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.
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:
Must be able to carry up to 25 lbs.,to 50 lbs., and push/pull > 100 lbs. (with the up lift 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
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 in a confined area.
Some Clean Room and cool/hot storage conditions.
May require immunization before performing work within the manufacturing area.
Shift Schedule: 2-2-3 Rotation, 6:00 PM – 6:30 AM
Includes a 10% shift differential on weekdays & 15% shift differential for weekend hours
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ
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Takeda Compensation and Benefits Summary
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