, remediation plans, and efficiency enhancements for lab operations. Report metrics on validation status, closures, and compliance... to internal teams. Coordinate system changes with QA/equipment owners, author validation protocols, and complete change...
quality risks. Lead and mentor people: provide quality guidance, apply risk‑based validation approaches, manage consultants... recruiting for a Lead, Digital Core to be located in Raritan, NJ, Beerse, Belgium; Mumbai, India and Bangalore, India...
, with 3+ years in a lead capacity. Hands-on experience in Computer System Validation (CSV) and Regulated Testing... candidate will have deep expertise in GxP regulations, computer system validation (CSV), and quality compliance...
into actionable technical roadmaps. Delivery & Execution Excellence Lead multiple global agile release trains and technology teams... across all PR&O technology teams. People Leadership Lead and develop a global team of Technology Product Managers, Engineers...
in a regulated environment. The role involves ensuring compliance with GxP standards through risk-based validation, supporting... multiple projects, and providing validation guidance while working collaboratively with cross-functional and remote teams...
environments. Support equipment validation, calibration, and qualification activities related to HVAC components, ensuring..., continuous improvement, and adherence to regulatory standards. Lead efforts to scope, plan, and implement HVAC system...
Summary Mandatory - Validation experience with ERP applications / SAP / MES Experience in validating ERP/SAP... communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work...
will also oversee Computer System Validation (CSV) and cybersecurity-related quality processes, ensuring regulatory compliance... and platform integrity. Key Responsibilities Lead governance of enterprise Quality IT platforms (eQMS, LIMS, data lakes...
and operational processes to deliver solutions for cost competitiveness. Lead the development of user requirements for new technology... and lead their development and implementation. Immerse yourself in CAR-T processes, build up proven expertise, ensure timely...
Engineer” based out of Branchburg, NJ. The Senior Manufacturing Engineer will lead and manage projects within filling.... Responsibilities Plan, design, and implement new manufacturing equipment and packaging processes. Lead cross-functional project...