About this opportunity
Avecia Pharma lists this Process Development Validation Scientist II opportunity in milford, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Process Development Validation Scientist II
About this opportunity
As a Process Development Validation Scientist, you will be responsible for drafting new Process Validation protocol and report documents to support process development, manufacturing, and validation activities. Responsible for drafting Risk Assessment Spreadsheets.
Key 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.
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.
Required Skills/Abilities
Bachelor’s Degree in a science‑related discipline and 6+ years related experience, 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 such aspects as process sampling and data trending analysis, knowledge of Minitab and SPC preferred.
The annualized salary range for this role is $89,500.00 - $109,500.00.
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Worksite address
milford, MA, 01757, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.