Validation Manager
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Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Role - Senior Validation Manager
Location - Raritan NJ(Hybrid)
Job Details:
Prior JNJ TQ Experience a must
Experience in validating QMS and different modules in QMS
5 years experience with System Development Lifecyle 10 years experience in Computer System Validation (Based on the role selected)
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Experience with QMS including giving guidance when a Non-Conformance has occurred on a system.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements Compliance Plans test protocols Test Summary reports and Compliance 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.
Preferred tools knowledge and experience: JIRA qTest ServiceNow XRAY and Change Record review
Technology Quality representative and provide quality guidance from a CSV perspective based on the J&J CSV Framework and SDLC process 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.
Location - Raritan NJ(Hybrid)
Job Details:
Prior JNJ TQ Experience a must
Experience in validating QMS and different modules in QMS
5 years experience with System Development Lifecyle 10 years experience in Computer System Validation (Based on the role selected)
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Experience with QMS including giving guidance when a Non-Conformance has occurred on a system.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements Compliance Plans test protocols Test Summary reports and Compliance 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.
Preferred tools knowledge and experience: JIRA qTest ServiceNow XRAY and Change Record review
Technology Quality representative and provide quality guidance from a CSV perspective based on the J&J CSV Framework and SDLC process 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.
Note - Prior Johnson & Johnson experience is must have.
The resource must have strong communication skills ability to lead a project as the primary Technology Quality representative and provide quality guidance from a CSV perspective based on the J&J CSV Framework and SDLC process. Knowledge/experience with CSA approach. AI/ML Validation experience would be a plus. Experience with QMS including giving guidance when a Non-Conformance has occurred on a system.
The resource must have strong communication skills ability to lead a project as the primary Technology Quality representative and provide quality guidance from a CSV perspective based on the J&J CSV Framework and SDLC process. Knowledge/experience with CSA approach. AI/ML Validation experience would be a plus. Experience with QMS including giving guidance when a Non-Conformance has occurred on a system.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
