- Lilly (Indianapolis, IN)
- …the world. **Organization Overview:** Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a ... supporting ongoing manufacturing at our External Partners through tasks such as process monitoring, response to issues, and improvements where necessary. A strong… more
- AbbVie (North Chicago, IL)
- …launch, including transfers both within and outside of AbbVie. + Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV. + Mentor/lead product ... team members through the design transfer process providing guidance to assure optimal approach. + Lead/support lifecycle design change projects following Design… more
- Takeda Pharmaceuticals (Cambridge, MA)
- 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 ... subject matter expert (SME), you will lead major technical transfer and validation projects related to new product development, launches, and lifecycle management.… more
- Lilly (Lebanon, IN)
- …and Startup Phase** + Support the safe, on time, and successful startup, process validation , and successful pre approval inspections. + Be a collaborative, ... currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredients (API) located in Lebanon, IN. This facility is Lilly's… more
- Sanofi Group (Framingham, MA)
- …Principal Manufacturing Compliance Engineer owns and ensures a robust investigations process , uses expert knowledge of compliance and GXP manufacturing processes to ... and implement appropriate Corrective and Preventative Action. + Utilize manufacturing process knowledge and investigation skill sets to identify and resolve… more
- AbbVie (Barceloneta, PR)
- …requirements are achieved. Responsibilities + Lead the biologics site micro laboratory process for a high volume, high level of product complexity including multi ... among others. Ensure robustness and approves Investigations Microbiology EM, quality and process excursions or incident. + Direct MEC laboratory operations such as… more
- PCI Pharma Services (Bedford, NH)
- …Serve as QA representative to cross functional project teams such as tech transfer, process validation , and process improvement + Coordinate change control ... including relevant quality metrics and participation in the management review process + Establish collaborative relationships with internal and external customers to… more
- Bristol Myers Squibb (Princeton, NJ)
- …automation, system upgrades, and stakeholder feedback.** + **Manage platform security, validation , and compliance in coordination with IT and cybersecurity teams.** ... HPC, Kubernetes, and parallel/distributed computing.** + **Familiarity with software validation , compliance, and best practices in regulated environments.** +… more
- PCI Pharma Services (Bedford, NH)
- …Serve as QA representative to cross functional project teams such as tech transfer, process validation , and process improvement + Coordinate change control ... including relevant quality metrics and participates in the management review process + Establish collaborative relationships with internal and external customers to… more
- PCI Pharma Services (Madison, WI)
- …Serve as QA representative to cross functional project teams such as tech transfer, process validation , and process improvement + Coordinate change control ... including relevant quality metrics and participates in the management review process + Establish collaborative relationships with internal and external customers to… more
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