- Merck (West Point, PA)
- …exception handling to ensure right-first-time execution. + Author and help execute validation deliverables (URS, CS/DDS, IQ/OQ) consistent with GAMP 5, 21 CFR Part ... SCADA, OPC UA, MQTT/Sparkplug, and historians. + Familiarity with validation lifecycle and SDLC documentation (URS/CS/DS/IQ/OQ and risk-based testing). **Preferred… more
- GE HealthCare (Bellevue, WA)
- …the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action ... design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …flows, ensuring accurate subledger and intercompany processing. + Lead the validation of R2R functional designs through SIT, UAT, regression testing, quarterly ... patch testing, and financial close mock cycles. + Oversee R2R data migration including journals, balances, AP/AR transactions, fixed assets, leases, and project financials conversions; ensure precise reconciliations. **This Job Might Be For You If You Have:**… more
- Boehringer Ingelheim (Athens, GA)
- …strategies for producing active ingredients through sterile filling, such as validation and cost optimization. The role also includes representing BIAH's interests ... in interactions with business contacts (customers, suppliers, etc.) both within and outside of BI. **Duties & Responsibilities** + Analyzes processes at the manufacturing site, focusing on implementing effective solutions to resolve problems. Leverage Asset… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …TAG team is using large-scale human exome sequencing for discovery and validation of new therapeutic targets in autoimmune and other immune-mediated disease. You ... will be responsible for designing and executing studies integrating large scale human genetics and multidimensional omics datasets derived from RGC and public resources in the immunology space to identify new targets for inflammatory and auto-immune diseases… more
- BeOne Medicines (Emeryville, CA)
- …relevant functions to implement and complete technology transfer activities and process validation + Provide leadership in the resolution of both technical and ... nontechnical issues + Track team activities and timelines to ensure that the deliverables are met timely + Prepare, distribute, and present project status to team, management, and other stakeholders **Support commercial drug product manufacturing** +… more
- GRAIL (Albany, NY)
- …and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change ... control processes. This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in… more
- Otsuka America Pharmaceutical Inc. (Jefferson City, MO)
- …Profound grasp of Machine Learning lifecycle - feature engineering, training, validation , scaling, deployment, scoring, monitoring, and feedback loop. + Have ... implemented machine learning projects from initiation through completion with particular focus on automated deployment and ensuring optimized performance. + Agile skills and experience + Experience in Healthcare (esp. US) industry is a plus. **Competencies**… more
- Lilly (Indianapolis, IN)
- …teams). + Mechanical aptitude (knowledge of mechanical equipment, controls, and validation for medical devices). + Knowledge of manufacturing (preferably discrete ... manufacturing). + Understanding of GMP and ISO requirements for drug delivery devices. + Familiarity with analytical test systems and test method requirements for drug delivery devices. **Additional Preferences** + Understanding of statistics and design of… more
- OneMain Financial (Baltimore, MD)
- …decision automation, particularly natural-language rule authoring and AI-assisted rule validation . + Ability to balance architectural vision with delivery ... discipline, ensuring solutions are delivered with quality, speed, and measurable business impact. OneMain Financial (NYSE: OMF) is the leader in offering nonprime customers responsible access to credit and is dedicated to improving the financial well-being of… more