- Takeda Pharmaceuticals (Lexington, MA)
- …specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive ... key technical role is responsible for change controls, manufacturing process validation , device product complaints, regular review of DHF, and post-market… more
- Hologic (Marlborough, MA)
- …lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory ... lifecycle. + Expertise in defining and executing robust software verification and validation (V&V) strategies, including test method validation . + Skilled in… more
- Takeda Pharmaceuticals (Boston, MA)
- …the strategic definition and cross-functional coordination of Target Identification and Validation (TidVal) tools and infrastructure. This role will be instrumental ... area strategies and research portfolio goals. + Partner with the Takeda Data and Digital (DD&T) team to co-develop scalable, interoperable, and future-ready TidVal… more
- Bristol Myers Squibb (Devens, MA)
- …for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/ validation ... Sunday - Wednesday 2PM - 12AM **Key Responsibilities** + Perform method transfer/ validation and routine testing of in-process, final product, and stability samples.… more
- Oracle (Boston, MA)
- …Semantic Agent Builder empowers teams to create high-value Al agents on our semantic data platform for use with the Oracle Health EHR. You will own the strategy ... and delivery of building an agent ecosystem, working with the semantic data platform and collaborating with teams including data science, engineering, and UX.… more
- Oracle (Boston, MA)
- …Semantic Agent Builder empowers teams to create high‑value AI agents on our semantic data platform for use with the Oracle Health EHR. This role leads a "no-code" ... and delivery of this "agentic development experience," working with the semantic data platform and collaborating with teams including data science, engineering,… more
- Sumitomo Pharma (Boston, MA)
- …for all in-scope applications, ensuring all system activities meet requirements for validation , change control, documentation, audit trails, and data integrity. ... the System Development Life Cycle (SDLC) for regulated systems, including validation planning, executing IQ/OQ/PQ protocols, and final report generation. + Act… more
- Oracle (Boston, MA)
- …+ **Governance & Compliance:** Design and advocate for robust governance models, validation tooling, and compliance protocols that prioritize data integrity, ... **Cross-Functional Collaboration:** Serve as the connective tissue between engineering, data science, clinical informatics, terminology experts, and EHR product… more
- Coinbase (Boston, MA)
- …activities include audit planning, stakeholder management, fieldwork execution, reporting and validation of remediated audit findings. * Develop audit reports on the ... response and the corrective action taken on internal audit findings, including validation of remediation activities. * Remain current and increase knowledge of… more
- Oracle (Boston, MA)
- …Agents-from concept to release. In this role, you will work closely with data science, engineering, and UX to explore new opportunity spaces, define gold-standard ... training data requirements, guide the model development lifecycle, and ensure...with clinical intent, performance benchmarks, and compliance standards. + Validation & Safety Testing: Develop validation protocols… more
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