US-IL, Clean Room Sanitizer - 1st Shift SR0029692-MZ
SUMMARY: Sanitization Associates are responsible for all activities associated with the manufacturing and filling operations at Takeda's Round Lake, Illinois manufacturing facility, required to produce sterile drug products under aseptic conditions; performs routine cleaning activities such as shiftly, daily, weekly and monthly cleanings in addition to any remedial cleanings that may be needed inside a controlled Clean Room environment; performs miscellaneous equipment set up, performs filter testing, and assists in the cleaning and preparation of small parts; adheres to cGMP, GDP, environmental health and safety guidelines, FDA regulations and any other related regulations which could apply; fully participates in both departmental projects and any quality working teams which may be applicable; under the general direction of the lead filling operator and the overall direction of the shift supervisor ESSENTIAL DUTIES AND RESPONSIBILITIES: Cleans and sanitizes aseptic production areas Sets up/prepares/cleans and autoclaves components (for example, washing disassembled equipment) Reading and understanding written instruction as detailed on production routers in the English language Adheres to routine clean room gowning practices Stocks consumable items, such as bouffants, beard covers, ear plugs, safety glasses, gloves and boot covers Stocks clean room gowns Removes and disposes of trash from fill room and gowning areas Documents activities in log books, forms, etc. in a legible manner as per cGMP Stays and continues to work until all cleaning activities are complete Must be available for overtime and weekends QUALIFICATIONS: Must be willing and able to work 1st shift: 7:00am-3:30pm, Monday through Friday Must be able to speak, read, write and follow detailed written and oral instructions in the English language Must have good written and oral communication skills and understanding of / compliance with current Good Manufacturing Processes (cGMP) regulations 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 20/25 vision or better within arm s length Must NOT be colorblind Familiarity with pharmaceutical production equipment, including autoclave, parts washer and CIP/SIP Good interpersonal skills and ability to work effectively and efficiently in a team environment This position requires shift, weekend and holiday work; overtime will be required at times (typically 2 Saturdays each month) Must work in a clean room environment, wearing special garments; additionally, personal protective equipment must be worn due to safety requirements Personal protective equipment must be worn due to safety, cGMP and FDA requirements Knowledge of basic chemical and biological safety procedures May require immunizations before performing work within the manufacturing area EDUCATION and/or EXPERIENCE: Requires AA degree with 1 year of manufacturing experience or High School diploma (or equivalent) with 2 years of related manufacturing experience PHYSICAL DEMANDS: Must be able to lift, push, pull and/or carry up to 40 lbs. Repetitive motions with hands, wrists, turning head, bending at knees and waist WORKING ENVIRONMENT: 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 May work in a cold, wet environment Must be able to work multiple shifts, including weekends Must be able to work overtime as required, including Saturdays May be required to work in a confined area May be exposed to some Clean Room and cool/hot storage conditions May require immunization before performing work within the manufacturing area
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.
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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.
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