- Astellas Pharma (Westborough, MA)
- …for commissioning and qualification of facilities/utilities, equipment, automated systems, and process validation . + Author, execute, review, and approve ... validation documentation for facilities/utilities, equipment, automated systems, and process validation and assist with resolving technical issues, evaluating… more
- Bristol Myers Squibb (Devens, MA)
- … and support requests. + Provides technical support and guidance on Validation , Quality Process and equipment qualification issues. Interfaces with customers ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key Responsibilities**… 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
- Insight Global (Boston, MA)
- Job Description We are seeking a dedicated Cold Chain Validation Specialist will support a fortune 500 pharmaceutical Logistics team. This team is involved in ... multiple cold chain and packaging studies, and this Validation Specialist will be gathering and organizing data to...our client's products are not impacted during the transportation process . We are a company committed to creating inclusive… more
- Eurofins (Cambridge, MA)
- …is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is ... function will be to support our client with GMP-related sample testing and method validation . The individual will also serve as a group leader, overseeing a team of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation . + Has full accountability for all engineering aspects ... processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs), piping… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." ... develops,** **manufactures** **and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for… more
- Merck (Boston, MA)
- …management of an important inflection point in the drug development process , working closely with scientific, regulatory, statistical, and modelling colleagues ... seeking a highly qualified physician-scientist with a proven track record in the pharmaceutical industry as well as independent academic research for a position in… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and the overall drug development process . + Demonstrated experience with process validation and regulatory requirements. NDA / MAA/ ANDA filing experience ... + Manages and executes activities related to drug product technology transfer, validation and process improvements to manufacturing partners. Oversees cGMP… more