Process Development Validation Scientist II

About This Opportunity

As a Process Development Validation Scientist, you will be responsible for drafting new Process Validation protocols and report documents to support process development, manufacturing, and validation activities. You will also draft Risk Assessment Spreadsheets.

• 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.
• Maintains an appropriate level of training on company and departmental procedures as determined by Avecia and Process Validation.

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

The annualized salary range for this role is $89,500.00 - $.