What are the responsibilities and job description for the Validation Specialist position at Sunrise Systems Inc?
Job Title : Validation Specialist
Job ID : 25-06624
Location : New Brunswick, NJ, 08903
Duration : 06 months of Contract on W2
Candidates should be 50% onsite at either New Brunswick or Lawrenceville. Please enter the preferred site on the resume under the candidate's name.
Onsite Tues, Wed or Thurs but EM is flexible. Normal business hours.
This is an urgent need so I will begin to qualify candidates before the 3 day SLA.
Please see scrubbed resume attached.
Must Have List
5 years of Client ALM
5 years of 21 CFR Part 11 experience
5 years of CSV with Biopharma space
Highly Preferred
Recent CLIENT experience.
LIMS implementation.
6 years' experience
Review computerized systems validation documents such as :
Requirements Specification
Design Specification
CSV Risk Assessment
Test Plans
Test Summary Reports
Data Migration Plan
Pre / Post Executed Test Scripts
Traceability Matrix
Release to Production Statements
Direct and review testing
Provide guidance on quality issues that affect the integrity of the data or the system
Obtain and respond to QA review
Participate in establishing standard quality and validation practices
Independently assess compliance practices and recommend corrective actions
Approve validated computer system related change requests
Monitor regulatory and inspection trends and advise the business on suitable action
Ability to create documents to an existing document standard.
Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Once trained, have the ability to work independently on CSV projects with minimal oversight.
Ability to perform in a highly matrixed organization structure
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