Recruitment Fraud Alert
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If you believe you have been contacted by an unauthorized person, please contact your local law enforcement agency immediately.
Manufacturing Technician II
Therole is responsible for executing all processes in productionwhile strictly adhering
to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routinerevisionstodocuments,he/she may rewrit e c omplex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledgetoperform complex trouble shooting tasks and may even assist during t he transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-artcGMPcompliance,andenvironmental health andsafetyskills.
- Prepare media and buffer solutions.
- Operate Clean-in-Place (CIP)and Steam-in-Place systems.
- Assemble andoperatefiltration systems.
- Operategeneral production equipment(such as pH andconductivitymeters,autoclave, portable mixers, etc.)
- Monitor andrecord critical processparameters.
- Complete all relevant paperwork following GDP/GMP guidelines .
- Perform routine maintenance and cleaning of productionequipmenttomaintain in GMP fashion.
- Perform sampling using aseptictechniques.
- Participate on ContinuousImprovement Teams.
- Trainand mentor other team members.
- Write, reviseandreviewpertinent documentation as appropriate.
- Troubleshoot process problemsandrespondtoprocess alarms.
- Assist with process/equipmentvalidationand data analysis.
- Work with other groups such as maintenance/metrologytoensurepreventative maintenance is done.
- Initiate and/or coordinate other process improvement projects.
- May perform other duties as assigned.
- Responsible to execute materialtransfers that includenon-hazardous,hazardousand flammable chemicals tosupportmanufacturingscheduleadherence.
- Maintain a visualreplenishmentprogram of materials using lean manufacturing processes/tools.
- Maintain records of materials in inventoryand on order.
- Compile inventory records as needed.
- Reconcile discrepancies in inventories.
- Compile information on receipt andtransfer of materials.
- Resolve questions andproblemsandrefers only most complex issues tohigherlevels.
- Contribute to a culture of safety first in compliance with Environmental,Health,and Safety (EHS).UnderstandandfollowJobHazardAnalysis(JHA)packets.
Education and Experience Requirements
- Typically requires high schooldiploma or GED plus 2+ years of experience or associates’ degree or higher and 1+ years of related work experience.
Key Skills, Abilities, and Competencies
- Knowledge of cGMP manufacturing.
- Knowledge of basic laboratoryandpharmaceuticalproductionequipmentincludingbut not limited to: autoclaves,process tanks, incubators,analyticalequipmentandCIP/SIP systems.
- Must be able toapplyquantitative analysis toanalyzeprocess performance.
- Incumbent must be proficient in a variety of mathematical disciplinesand be able towork with both the metric and USA standards of measurement.
- Must be able toreadandfollow detailed written instructions andhavegoodverbal/written communication skills. Goodproceduralwriting skills.
- Knowledge of basic chemical andbiological safety procedures.
- Good computer skills, knowledge of Microsoft Word andExcel.
- Very goodinterpersonal skills and be able toworkeffectivelyand efficiently in a team environment.
- Must haveand display the followingpersonal attributes: Integrity,trust,workethic, sound judgment, intellectual honesty, and conviction.
- Must have experience with inventory management.
- Experience in handlingpallet-jacks,pallettrucks,andforkliftsare a plus.
Other Job Requirements
- Must be able to carry up to 25 lbs., lift up to 50 lbs., andpush/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 andstairswhilewearing special gowning.
- May requirebending, twisting, reaching overhead, and/or squatting motionstoperform certain tasks.
- Must be able towork in controlled environmentsrequiringspecialgowning. Will be requiredtofollow gowningrequirementsandwearprotective 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
- Will work in a cold, wet environment.
- May be working in a loud area that requireshearing protection and other protective equipment to be worn.
- Willworkaround chemicals such as alcohol that may requirerespiratoryprotection.
- Must be able towork multiple shifts, includingweekends.Must be able toworkovertime as required.
- May be requiredtowork in a confinedarea.
- Some CleanRoomand cool/hot storageconditions.
- May require immunization beforeperformingwork within the manufacturingarea.
EEO Verbiage for US Reqs
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.