- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …environments and regulatory requirements (FDA, EMA, ICH). + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management… more
- NTT DATA North America (MA)
- …delivering robust, scalable, and compliant integration solutions within a pharmaceutical manufacturing environment. Strong technical leadership in SAP integration ... CFR 21 Part 11, and other regulatory requirements applicable to pharmaceutical operations. **Key Responsibilities:** + Lead the end-to-end design and implementation… more
- Takeda Pharmaceuticals (Boston, 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 ... to the best of my knowledge. **Job Description** **OBJECTIVE:** Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and… more
- Sanofi Group (Cambridge, MA)
- …Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute building the Human Target Validation ... of multiple disciplines into a coherent translational medicine and human target validation plan is essential. We are an innovative global healthcare company with… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management ... performance, identify trends, and propose process improvements. + Support process characterization and validation activities (PPQ) for upstream processes… more
- Integra LifeSciences (Braintree, MA)
- …of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + Knowledgeable of and applies statistical ... results. + Supports developing statistically based sampling plans for Design Verification and Validation , Process Validation , or other studies as deemed… more
- Integra LifeSciences (Braintree, MA)
- …implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + Maintains knowledge of and applies ... of results. + Develop statistically based sampling plans for Design Verification and Validation , Process Validation , or other studies as deemed necessary.… more
- AbbVie (Worcester, MA)
- …Automation and Controls to lead site Automation team within our pharmaceutical operation reporting into Digital Systems organization. This role is responsible ... of automation systems. + Maintain documentation including functional specification, validation protocols and change controls. + Experience in change control,… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and… more
- Sanofi Group (Framingham, MA)
- …infrastructure + Experience with systems/network/ validation , preferable in the chemical, pharmaceutical , foods, or other process industries is preferred + ... a new or revised digital systems, the design, installation, verification and validation of the system, the maintenance of the system in its… more
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