- Takeda Pharmaceuticals (Lexington, MA)
- …per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory ... Reports (VSR) etc. per Food Drug Administration (FDA) and other US pharmaceutical regulations; Analyze validation data, prepare reports and make recommendations… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in ... and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards… more
- Bristol Myers Squibb (Devens, MA)
- …careers.bms.com/working-with-us . **Summary:** The Senior Engineer - IT Computer System Validation , Cell Therapy Devens role will provide support to the Digital ... the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change… more
- Nestle (Waltham, MA)
- …is preferred. * Experience with authoring and reviewing technical content in support of process validation and/or regulatory filings such as IND, BLA, PAS is ... NHSc's pharmaceutical products. **Key Responsibilities:** * Serve as a process SME for NHSc products and manufacturing processes, providing troubleshooting and… more
- Sanofi Group (Framingham, MA)
- …modeling workflows. + Support mechanistic modeling initiatives for bioprocessing or pharmaceutical unit operations, including model calibration, validation , and ... **Job Title:** Winter/Spring 2026 Co-op-Intern - Process Modeling - Data Science - MSAT **Grade:**...concepts is a plus. + Familiarity with bioprocesses or pharmaceutical unit operations. + Experience working with data visualization… more
- AbbVie (Worcester, MA)
- …knowledge, engineering knowledge, and mathematics, to lead equipment and process troubleshooting, New Product Introduction (NPI), manage/support medium to large ... improvement, and considers EHS aspects during day to day activities. + Oversees process monitoring of manufacturing operations, as well as Steam in Place (SIP) and… more
- Amgen (Cambridge, MA)
- …responsible for late phase analytical development, including method development, method validation , method transfer, process and product development support, and ... Biochemical or Chemical Engineering. + 2+ year's post-PhD experience in the pharmaceutical or biotech industry in process development and drug substance,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. Under supervision, the scope of ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
- Amgen (Cambridge, MA)
- …independent scientific research + Four or more years of experience in pharmaceutical process development with related experience in analytical support, execution ... Join us and transform the lives of patients while transforming your career. Process Development Principal Scientist **What you will do** Let's do this. Let's change… more
- Takeda Pharmaceuticals (Boston, MA)
- …for a project area/technical program within the department and potentially across Pharmaceutical sciences. + Stay current in novel process modeling and ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
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