Regulatory Validation Lead — GxP, SaaS & AI

BayOne Solutions; Raleigh (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

BayOne Solutions in Raleigh seeks a Validation Specialist, Regulatory to help implement GxP computerized systems for the R&D IT department. The role emphasizes CSA experience, knowledge of US/EU regulations, and validation of SaaS applications and AI models.

You will write validation deliverables, training materials and SOPs, support electronic validation tools, and lead system implementation with change management while maintaining compliance. Hybrid work, 3 days in office.

Qualifications

• Bachelor’s degree in computer science / information systems or related discipline.
• 3 – 5 years of experience in a position of equal scope and responsibility.
• Experience in the pharmaceutical or medical device industry.

Responsibilities

• Ability to write validation documents to support the implementation of software applications including change controls, validation plans, user requirements, and testing documentation
• Ability to write training documentation, User and Admin SOPs, as applicable
• Experience with electronic validation applications preferred
• This activity constitutes ~40% of the job description
• Ability to implement GxP computerized systems, including project management configuration, user acceptance testing, and hypercare
• Ability to drive user adoption of the new application through training and change management
• Ability to maintain the validated state of applications in accordance with policies and procedures
• This activity constitutes ~50% of the job description
• Experience with Computer System Validation, Computer Software Assurance and GxP relevant applications
• Experience with writing standard operating procedures, validation deliverables, training material
• Experience running projects and strategy initiatives

Job description

BayOne Solutions in Raleigh seeks a Validation Specialist, Regulatory to help implement GxP computerized systems for the R&D IT department. The role emphasizes CSA experience, knowledge of US/EU regulations, and validation of SaaS applications and AI models.

You will write validation deliverables, training materials and SOPs, support electronic validation tools, and lead system implementation with change management while maintaining compliance. Hybrid work, 3 days in office.