What are the responsibilities and job description for the Validation Engineer - II position at ATR International?
Job Description :
We are seeking a Validation Engineer - II for a very important client.Responsibilities :
- Strong background in statistics, process monitoring and advanced statistical data analysis.
- Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.
- Author, review and approve CPV protocols, reports and present CPV data as needed to Subject Matter Experts (SMEs).
- Support batch processing data collection and verification activities.
- Identifies and implements improvements for data collection and management to enable quick and reliable data analysis.
- Provides statistical expertise for all global commercial process monitoring in compliance with current ICH / Health Authority, QbD guidelines and SOPs.
- Assist in resolution of investigations doing statistical analysis.
- Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within generally defined practices and policies in selecting statistical methods, techniques and evaluation criteria for obtaining results.
Requirement :
The ideal candidate should possess the following qualifications : Knowledge and Skills