Validation Specialist

Validation Specialist - Princeton, NJ

About Us: We are the people putting people back to work. We are the leaders of the new normal and we have been since 1997. Providing jobs, solutions and a deep competence for a new economy. We supply the skills that propel life forward. We inspire individuals to find their third, fourth and their umpteenth gear. We are an engine of opportunity. We are the gateway from good to great.

Welcome to the new normal. Welcome to Integrity Staffing Solutions. Engine of Opportunity.

Our client is a global leader in the BioPharma industry. Their mission is to "discover, develop, and deliver innovative medicines to patients with serious diseases." They are committed to scientific excellence and investment in biopharmaceutical research and development to provide innovative, high-quality medicines that address the unmet medical needs of patients with serious diseases.

Key Responsibilities:

Our client is looking for qualified candidates that have a minimum of 6+ years' experience:
• Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes
• Conduct training on good documentation and good testing practices
• 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:
o Requirements Specification
o Design Specification
o CSV Risk Assessment
o Test Plans
o Test Summary Reports
o Data Migration Plan
o Pre/Post Executed Test Scripts
o Traceability Matrix
o Release to Production Statements
• Direct and review testing
• Provide guidance on quality issues that affect the integrity of the data or the system
• Prepare validation summary and test summary reports
• 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
• Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms
• Working knowledge of Documentum.
• Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
• Experience in producing software documentation and business requirement documentation (minimum 3 yrs); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.

Additional Details:
• Employment Type: Contract with possible extension and/or permanent employment conversion
• Supplemental medical and dental coverage for contractors and their families available immediately
• Opportunities for professional growth

Integrity Staffing Solutions is an Equal Opportunity Employer. All job offers are contingent upon the successful completion of a background check and drug screen.

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