Validation Lead California-Silicon Valley/Peninsula
7/28/2016 2:05 PM

Executing and managing process validation activities, primary packaging validation activities, cleaning validation activities and complex revalidation activities strategies to meet cGMP requirements on time and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs. Validation Master Plan • Lead writing and maintaining Validation Master Plan for  ...View Job
Quality Site Head California-Silicon Valley/Peninsula
7/28/2016 2:04 PM

This position leads the site Quality Department (QA/QC) PharmOps function to ensure that all processes, procedures, tasks, responsibilities, and projects are in compliance with cGMP requirements. In addition, this position has complete leadership, managerial, and budgetary responsibility for the Quality Department. • Must be able to develop and communicate the Quality vision and strategy and b  ...View Job
Sr. Project Engineer California
7/28/2016 1:34 PM

Supporting the project engineering team with construction and safety supervision on all engineering projects, ensuring all applicable Novartis policies, guidelines, and procedures are followed in the compliant execution of construction and start-up activities. Plans and coordinates assigned project work as lead or in support of the assigned lead project manager(s)/engineer(s). Monitors work for co  ...View Job
Device Expert California-Silicon Valley/Peninsula
7/28/2016 1:31 PM

The Device Expert is responsible for the device and its documentation after transfer from TRD to TechOps throughout the whole Life Cycle until pruning of the device. This includes the management of changes, deviations and suppliers as well as ensuring all post launch activities are conducted according to regulations. As the receiver of assigned devices and the related Design History file/Design Do  ...View Job
Process Expert California-Silicon Valley/Peninsula
7/25/2016 8:51 AM

Supports the PU in all process-specific issues, drives continuous process improvement for quality and quantity and ensures GMP requirements are met and guidelines and SOPs are followed. • Provide continuous supply of high quality products that meet technical specifications, cGMP, regulatory policies and procedures. • Root cause analysis and investigation for deviations and complaints (extern  ...View Job
Process Unit Coordinator California
7/8/2016 6:23 PM

Leads and supports the daily production operation within the Process Unit to produce and deliver high quality products to customers in a compliant, timely, efficient, and cost effective manner. Ensure full compliance with Health, Safety and Environment (HSE), Good Manufacturing Practices (GMP), statutory, regulatory, and Novartis requirements. • Translate PU targets into daily operational plan  ...View Job