Computer Systems Validation Lead
Location:
Horsham , Pennsylvania
Posted:
March 10, 2017
Reference:
8243170127-en-us

Janssen Research and Development, LLC, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Computer Systems Validation Lead. This role will be located in Horsham, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information. 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The objective of this position is to develop and deliver the validation strategy and documentation for safety tools and safety systems.  The Validation Specialist works closely together with team members within Global Medical Safety.

The validation specialist leads the development of the validation approach for all tools and systems.  This is a business critical function to ensure the delivery of validated systems for evaluation of safety data by the GMS. The validation specialist will be leading the development of all SDLC deliverables, including user requirements, UAT scripts, and associated documentation. The Validation Specialist will manage a portfolio of validation projects and timelines. The function will partner with other GMS functions on defining future systems strategy to optimize GMS surveillance capabilities.

Major responsibilities:

Provide validation deliverables defined in applicable Computer System Validation (CSV) SOPs, including:
•Compliance Plan
•Compliance Analysis
•Compliance Report
•Database Design Documents
•Technical Design Specifications
•IAPP Deployment Questionnaire
•IQ Protocol
•IQ Checklist
•IQ Reports
•Security Configuration Specifications
•Traceability Matrix
•UAT Reports(User Acceptance test Protocol, User Acceptance Test Script, User Acceptance Test Report)
•User Requirement Specifications
•Consolidated validation document: Risk Analysis and Validation Requirement Report( RAVRR)
•SS-CSV Documentation
•Change Control Documents
•Dry run of UAT Test Scripts


Qualifications

•Bachelors and 8 years of CSV experience required or 4 years CSV experience with a Master’s degree in Computer Science ,Informatics or equivalent required
•In-depth knowledge of SDLC (System Development Lifecycle) required
•Experience in computer system validation required 
•Knowledge of regulatory safety reporting databases required
•Experience with DOCSPACE or standard documentation system preferred
•Experience with MedDRA preferred
•Experience with SAS/JMP required 
•Previous pharmaceutical experience preferred
•Ability to work as part of a team.  
•Problem solving abilities and skills.
•Clear concise documentation skills.
•Strong written and verbal communication skills.
•Attention to detail
•Demonstrated understanding of basic statistical principles required.



Primary Location
United States-Pennsylvania-Horsham
Organization
Janssen Research & Development, LLC. (6084)
Job Function
IT Compliance

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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