US-MA, Senior Validation Engineer SR0037850-MZ
In support of site projects, technical transfers, and ongoing validation maintenance, this position will be primarily responsible for the design, authorship, and execution of qualification studies for the following major systems:
As required, this position will provide technical SME support to change controls, deviations, and CAPAs.
The scope of responsibility for this position includes commissioning and qualification, and maintenance of the validated state, of all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug substance platforms.
30% - 80% of Time:
Design, Author, execute, and summarize qualification activities in the following areas:
Provide SME input to the following Quality System elements as a representative of the validation group:
Provide SME input to the following site initiatives as a representative of the validation group:
10% - 20% of Time
Education and Experience Requirements
Bachelor's in Biology, Chemistry, Chemical Engineering or related field with a minimum of 7 years relevant experience
Master s in Biology, Chemistry, or Chemical Engineering with a minimum of 5 years relevant experience.
Key Skills, Abilities, and Competencies
Qualified candidates will demonstrate:
Complexity and Problem Solving.
The successful candidate will:
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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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