What are the responsibilities and job description for the VALIDATION - Validation Specialist position at Tech Providers Inc.?
Job Title: Validation Specialist
Location: New Brunswick/ Lawrenceville, NJ/ Hybrid
Duration: 6 months contract with possible extension
Job Responsibilities:
(50% onsite at either New Brunswick or Lawrenceville- Onsite Tues, Wed or Thurs but EM is flexible. Normal business hours)
FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
Follow SOPs and industry best practices
Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
• Review computerized systems validation documents such as:
• Requirements Specification
• Design Specification
• CSV Risk Assessment
• Test Plans
• Test Summary Reports
• Data Migration Plan
Duties:
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
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.
Requirements:
6 years’ experience
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
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
Location: New Brunswick/ Lawrenceville, NJ/ Hybrid
Duration: 6 months contract with possible extension
Job Responsibilities:
(50% onsite at either New Brunswick or Lawrenceville- Onsite Tues, Wed or Thurs but EM is flexible. Normal business hours)
FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
Follow SOPs and industry best practices
Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
• Review computerized systems validation documents such as:
• Requirements Specification
• Design Specification
• CSV Risk Assessment
• Test Plans
• Test Summary Reports
• Data Migration Plan
Duties:
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
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.
Requirements:
6 years’ experience
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
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
