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AbbVie 的使命是發現並提供創新藥物,解決當今嚴重的健康問題,同時面對未來的醫學挑戰。除了 Allergan Aesthetics 產品組合中的產品及服務外,我們還致力在幾個關鍵治療領域為人們的生活帶來顯著影響:免疫學、腫瘤學、神經科學、眼科、病毒學、女性健康和胃腸病學。如需瞭解更多有關 AbbVie 的資訊,請造訪我們的網站。在 Twitter、Facebook、Instagram、YouTube 和 LinkedIn 追蹤 @abbvie

Process Scientist - OSD and Fill Finish

次要 科克, 爱尔兰 職位 ID 2216846 類別 Research and Development 部門 AbbVie

Want to make a global impact? We offer that.
Want to be part of a Great Place to Work in Ireland? We offer that too.
Welcome to AbbVie!


We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.


We are recruiting Process Scientist - Fill finish and OSD (2 year contract) to join our diverse team in CarrigtwohillCork. The Process Scientist will work within the Site Technology team to provide analytical support to scale-up, product support and clinical supply projects. This role will support all analytical aspects of a product’s life cycle from development through to commercial manufacturing. This role will involve working within the Site Technology team and will require the following activities:


Are you intrigued? Do you want to learn more?

  •  Support and lead, scientific, engineering, and operational leadership programs for the introduction new products into the commercial facility
  • Involves high levels of cross functional collaboration, technology transfer, process scale up, process performance monitoring and optimization and continuous improvement.
  •  Act as Subject Matter Expert (SME) for fill finish operations and processes
  • The role will contribute to process understanding, manufacturing best practices for filling technology with focus on the continuous improvement.
  • Provide technical input to technology transfer related documents (e.g., clinical, and commercial Validation protocols, batch records)
  • The role will also support all aspects of new technology introduction, plant performance, process improvements, cGMP compliance and troubleshooting as part of the product support role during the commercial life span of the product
  • Support the performance of validation activities deemed within the scope of Site Technology, including cleaning, laboratory equipment and process validation
  • Support all aspects of a product life cycle, including development, registration, clinical and commercial manufacture
  • Support the Site Technology department in meeting departmental and site KPI’s
  • Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues 
  • Provide SME input to aseptic filling and visual inspection, including technical assistance and deviation investigation
  •  Manage and lead the startup activities, will provide investigational support, lead and/or contribute to STE lab studies 
  • Provide direction and leadership with respect to future process improvement activities 
  • Assist in the selection of the appropriate technologies to support the product manufacture
  •  Support/lead the selection process for introduction of new analytical/process equipment and the process of the introduction of new methods and procedures
  • Develop SOPs to support the new equipment and methods
  • Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, or technologies
  • Be familiar with the products, the manufacturing techniques, and procedures.
  • Trending of process data and correction of product issues
     

  • 3rd level technical/scientific qualification in biochemistry, Chemical, biochemical engineering, or related field with 4+ years relevant experience to Ph.D level desirable. 
  • Aseptic drug product experience in sterile fill finish operations and/or DP visual inspection and defect library creation and maintenance is highly desirable
  • Ability to manage both projects and day to day activities. Ensure that priorities are effectively established and controlled. 
  • Be able to take the necessary guidance and instruction on both cGMP and technical projects where required. Demonstrate a commitment to identifying and improving the management processes for the effective control of the activities.
  • Experienced in cGMP and large-scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.

So, are you ready to join our team?


It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.


AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.


出差: Yes, 10 % of the Time
工作類型: Experienced
工作時間: Full-time
ABBVIE

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