US-IL, Fill Room Operator SR0032847-MZ
Fill Room Operator
The Fill Room Operator 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 general direction of the lead technician and 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 making routine revisions to documents, he/she may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the 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-art cGMP compliance, and environmental health and safety skills.
Essential Duties and Responsibilities:
1. Supports all local manufacturing operations.
2. Supply components, small parts, glassware, tubing, etc. to cell culture and purification areas.
3. Operate general production equipment (such as parts washers, autoclave, stir plates, etc.)
4. Complete relevant paperwork following GDP/GMP guidelines.
5. Manually clean all portable equipment and small parts.
6. Participate on Continuous Improvement Teams.
7. Receive and distribute supplies into the production area as necessary.
8. Perform daily cleaning of the production area to maintain in GMP fashion.
9. Prepare media and buffer solutions.
10. Assemble and operate filtration systems.
11. Write, revise and review pertinent documentation as appropriate.
12. Train and mentor junior level technicians.
13. Troubleshoot process problems and respond to process alarms.
14. Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
15. Initiate and/or coordinate other process improvement projects.
16. May perform other duties as assigned.
Education and/or Experience:
Requires AA degree with 2-4 years experience or high school diploma with 4-6 years related manufacturing experience.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Please visit our website at takedajobs.com