Senior Validation Specialist

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry.

As a Validation Specialist you will be responsible to ensure system compliance with applicable regulations and that all testing is executed and documented according to Standard Operating Procedures and associated processes. This role is directly responsible for timely delivery of these requirements along with the management of the validation process and scope planning to support the execution of the testing of the requirements.

• Author functional business requirement specifications for new product features in cooperation with Product Management
• Perform risk assessment for new and modified functionality to determine GxP impact and appropriate validation approach
• Manage the validation process cycle including scope planning, test plan and script review, and end to end resolution cycle
• Confirm consistent traceability of design documents to functional business requirements
• Maintain and configure test environment for the purposes of test review and execution
• Oversee the development of key computer system validation deliverables

• 5+ years of direct experience with computer systems validation within the pharmaceutical industry
• Proven track record of leading computer systems validation projects for the life sciences
• Advanced knowledge of requirements engineering, test environments, protocol development, and functional risk assessment
• Excellent verbal and written communication with the ability to present complex design concepts into clear and concise requirements
• Self-motivated, resourceful, and able to meet responsibilities with minimal direct supervision
• Experience with 21 CFR Parts 11 and 203
• Bachelor’s Degree from a 4 year accredited institution

Nice to Have:

• Experience with SaaS based solutions, especially Salesforce.com