Full Description

Validation Specialist Princeton, NJ 6 months

Note: this position is for Computer System Validation specialist. Candidate is expected to have experience leading CSV efforts and not just testing experience. A candidate with strong testing experience with broader knowledge of CSV may be considered.

This role will be responsible to guide project teams through validation process, perform regulatory risk assessments, author, review and approve validation documentation, change requests and testing. He/She will work closely with the application test teams to ensure quality of validation deliverables and testing.

EM may need additional resources so keep your pipelines full. There will be a duplicate requisition coming with the same manager. Please do not submit the same candidates. As we make offers on initial requests, we will continue to duplicate them so that we can onboard more talents.

Must Haves

• Good communication skills
• 3-5 years of CSV lead experience
• 3-5 years of Client ALM
• 3-5 years of CSV Documentation author and review, approve
• 1-2 years of experience in Change Control
• Should be able to work with minimal supervision

Nice to have Experience/understanding of Data Integrity concepts Understanding of GAMP categories and validation approaches

Job Description

• 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