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*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info.
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takedas long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the worlds leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.
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Job ID SR0038332 Date posted 09/05/2019 Location Lexington, Massachusetts
This Sr. Engineer II is a technical leader who is a member of the Commercial Device Engineering (CDE) team accountable for leading the technical aspects of medical device and combination products that are on-market products for drug delivery. These products enhance patient and medical professional experiences with Takedas medicinal drug products.
In particular, this technical leader has significant experience in medical devices for drug delivery, including reconstitution devices or their subcomponents, and injection devices (prefilled syringes, autoinjectors) or their subcomponents, especially as these are used for lyophilized drugs. These devices may be used for intravenous or subcutaneous drug delivery. This key technical role will be responsible for or give input for change controls (proces, material, etc.), manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role may interact with external Contract Manufacturing Organizations (CLOs) and Contract Manufacturing Organizations (CMOs).
This individual will become a subject matter expert (SME) in commercial device drug delivery products, and has experience in risk assessments, device design control and device manufacturing with respect to technical, regulatory and quality issues. The individual shouldhave significant medical device experience in design and manufacturing. Experience in drug delivery is highly preferred with experience in bio/pharmaceutical industry highly preferred.
This CDE position is within Takedas Medical Device Center of Excellence (MD CoE) and will have cross-functional interaction with: Development Device Engineering for Device Tech Transfer, with Product Quality; Device Quality; Device Regulatory. Experience in QMS such as Trackwise, or similar, with ability to learn details Trackwise is required. The successful candidate will work in a team environment and establish strategic working relationships.
Responsibilities (% of time):
70%: Product and Technical Excellence:
20%: Team Leadership and Effectiveness :
10%: Supplier Relationship, Compliance, Quality and Operational Excellence:
Education: BS degree in an engineering discipline and minimum 7 years of experience, MS degree with minimum 6 years of experience, or PhD with minimum 4 years of experience, with focused disciplines in engineering such as chemical, mechanical, biomedical, materials, or similar credentials.
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 Takedas 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-###-#### and let us know the nature of your request and your contact information.
Job ID SR0038332
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Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.
At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.
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