Validation Specialist in New Brunswick, NJ

Candidates should be 50% onsite at either New Brunswick or Lawrenceville.

This is an urgent need so I will begin to qualify candidates before the 3 day SLA

Must Have List

• 5+ years of HP ALM
• 5+ years of 21 CFR Part 11 experience
• 5+ years of CSV with Biopharma space

Highly Preferred

• LIMS implementation.

Duties

• 6+ years’ experience
• Apply 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 validation deliverables for projects which are contracted to third party suppliers
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
• Assist in planning, implementing, and documenting user acceptance testing

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. HP 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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