Computer System Validation-CSV Engineer
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Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Key Responsibilities:
7 years of relevant experience; can work independently and guide/mentor Junior resources.
Experience in the Pharmaceutical biotechnology or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Knowledge of FDA guidances and industry standards (i.e. GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements Compliance/validation Plans test protocols Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts Traceability matrix and Design Specs.
Experience in QA Methodologies designing reviewing and approving Test Plans systems and UAT test scripts and Test procedures.
Ability to Review Automated Test script Strong verbal and written communication skills.
Ability to work as a team player lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance timely reviews and escalations to TQ management.
Hands on experience with validation of Data Solutions is preferred.
7 years of relevant experience; can work independently and guide/mentor Junior resources.
Experience in the Pharmaceutical biotechnology or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Knowledge of FDA guidances and industry standards (i.e. GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements Compliance/validation Plans test protocols Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts Traceability matrix and Design Specs.
Experience in QA Methodologies designing reviewing and approving Test Plans systems and UAT test scripts and Test procedures.
Ability to Review Automated Test script Strong verbal and written communication skills.
Ability to work as a team player lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance timely reviews and escalations to TQ management.
Hands on experience with validation of Data Solutions is preferred.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
