Contract: Process Validation Scientist / USA

The client is currently recruiting for a Process Validation Scientist based in Carlsbad, CA on a 12 month contract.

They are seeking a dynamic, proactive Process Validation Scientist to join their consumables center-of-excellence located in Carlsbad, CA.

As a core member of their 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.

Responsibilities:

• 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.
• Assist writing 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.
• May train manufacturing associates.
• Plan and conduct proof of concept or process feasibility experiments.

Skills:

• 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.

Education and Experience:

• MS Degree in Chemistry or Chemical Engineering OR BS Chemistry or Chemical Engineering with 3 to 4 years Life Science chemistry and/or consumables, sustaining, manufacturing or manufacturing process engineering.
• Background in Mass Spectrometry is a nice to have.