Process Validation Scientist OR Process Validation Engineer

Job Description

We are seeking a dynamic, proactive Process Validation Scientist to join our consumables center-of-excellence located in Carlsbad, CA. As a core member of our manufacturing team you will collaborate with cross-functional teams to incorporate design changes for existing products and will support transfer projects. In addition, you will work closely with R&D, Quality, Regulatory, Procurement and Manufacturing counterparts in order to establish and maintain technical documentation in accordance to Company procedures and guidelines.

Plan and conduct independent work requiring root cause analysis, troubleshooting, and modification of manufacturing processes triggered by engineering change orders, non-conformances, or process validation feasibility runs in support of production. Write process validation protocols (IOPQ/TMV) and work with R&D, Manufacturing and Quality teams to complete and assure high confidence and successful results. Confirm the accuracy of bills of material, item masters and other relevant product documentation. Complete assigned tasks related to design change processes and design transfers per Company procedures and guidelines. Train manufacturing associates.

Plan and conduct proof of concept experiments.

Ability to work independently and to perform assignments with no to moderate direction, while working together with cross-functional teams. Ability to explain sophisticated information to others. Ability to seek sophisticated problems; take a fresh opinion using existing solutions.

Ability to train and mentor manufacturing personnel and lower level technical team members. Ability to communicate key business-related issues or opportunities to senior level management.

Experience in chemistry or consumables manufacturing environment.

Ability to lead multi-functional sophisticated projects.

Ability to think and execute efficient solutions to existing manufacturing processes.

MS Degree in Chemistry or Chemical Engineering OR BS Chemistry or Chemical Engineering with a minimum of 2 years Life Science chemistry and/or consumables, sustaining, manufacturing or manufacturing process engineering.

Background in Mass Spectrometry is a nice to have.

Qualifications

Background in Mass Spectrometry is a nice to have.

Additional Information

All your information will be kept confidential according to EEO guidelines.