Process Development Validation Scientist II

Nitto Denko Corp. • Milford, MA

10d

About The Position

As a Process Development Scientist, you will be responsible for drafting new process validation protocol and report documents to support process development, manufacturing, and validation activities. You will be responsible for drafting Risk Assessment Spreadsheets and reporting the status of assigned activities to Process Development Validation leadership.

Requirements

• Bachelor’s Degree in science-related discipline and 6+ years related experience, Master’s degree and 3+ years related experience in science-related discipline.
• Knowledge of ICH guidance related to GMP and Process Validation.
• Excellent written and verbal communications, including technical writing.
• Microsoft Office Software.
• Knowledge of statistics and its application to such aspects as process sampling and data trending analysis, knowledge of Minitab and SPC preferred.

Responsibilities

• Preparation of Process Validation protocols / reports, CPV protocols and reports, PC&P reports, and VMP / VSR to enable Avecia’s process validation programs to be executed efficiently.
• Preparation of Manufacturing Study Protocols and associated reports.
• Creates new Process Validation document templates.
• Drafts Risk Assessment Spreadsheets
• Contributes to Initial and Final Risk Assessment activities.
• Contributes to investigations of OOT results during CPV and OOS/CAPA results during manufacture of validated products.
• Prepares and delivers PPQ training.
• Maintain an appropriate level of training on company and departmental procedures as determined by Avecia and Process Validation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees