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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. 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.
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.
Train and mentor other team members.
Write, revise and review pertinent documentation as appropriate.
Troubleshoot process problems and respond to process alarms.
Assist with process/equipment validation and data analysis.
Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
Initiate and/or coordinate other process improvement projects.
May perform other duties as assigned.
Typically requires high school diploma or GED plus 2+ years of experience or associates’ degree or higher and 1+ years of related work experience.
Knowledge of cGMP manufacturing.Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.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 be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills.Knowledge of basic chemical and biological safety procedures.Good computer skills, knowledge of Microsoft Word and Excel.Very good interpersonal skills and be able to work effectively and efficiently in a team environment.Must have and display the following personal attributes: Integrity, trust, work ethic, sound judgment, intellectual honesty, and conviction.
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.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.May be working in a loud area that requires hearing protection and other protective equipment to be worn.Will work around chemicals such as alcohol that may require respiratory protection.Will handle non-hazardous, hazardous and flammable materials/chemicals.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.
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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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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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