Process Development Validation Scientist II
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Job Location:
Milford, DE - USA
Monthly Salary:
$ 89500 - 109500
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
About this opportunity :
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.
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.
- 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 position is $89500.00 - $109500.00.
Required Experience:
IC
Key Skills
- Fire Protection
- Attorney At Law
- Cost Estimation
- Cloud Services
- Art & Design
About Company
Nordea is a leading Nordic universal bank – we are a strong and personal financial partner with financial solutions that best meet your needs so you can achieve your goals and realise your dreams.
