Process Development Validation Scientist II
Job Location:
Job Location:
Milford, CT - USA
Monthly Salary:
$ 89500 - 109500
Monthly Salary:
Posted on:
4 hours ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 Avecias 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.
Required Skills/Abilities:
- Bachelors Degree in science-related discipline and 6 years related experience Masters 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.
- 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 $89500.00 - $109500.00.
Required Experience:
IC
