Validation Engineer, Consultant

Company Overview:

One Vector is a rapidly growing IT professional services startup specializing in AI/ML, Data Science, Analytics, IT Quality/Compliance, and Pharmacovigilance for biotech companies. Our mission is to empower biotech organizations with cutting-edge solutions and expert insights to drive their success. As we continue our rapid expansion, we are seeking a dynamic and experienced Computer System Validation (CSV) Specialist to join our team.   

Position Overview:

We are seeking a highly skilled and motivated Software Validation Engineer professional to support the validation lifecycle of GxP regulated computerized systems. The ideal candidate will have a strong background in computer systems validation (CSV), quality systems, and Software Development Life Cycle (SDLC) principles. This role is pivotal in maintaining the integrity, reliability, and compliance of digital systems supporting manufacturing, laboratory, and business functions for our clients. 

This candidate will act as a trusted advisor to our clients, guiding them through the complexities of regulatory compliance while also ensuring the effective implementation and ongoing management of their computerized systems and Lifecycle procedures with Data Integrity requirements. Exceptional communication skills and the ability to forge strong relationships with clients are essential for this role. The successful candidate will be strategic, results-oriented, and committed to driving the company's growth in the biotech sector. 

Key Responsibilities:

• Lead validation activities across the full lifecycle of GxP systems including planning, testing, deployment, and periodic review.   
• Develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), Validation Reports (VR), and DM (Data Migration) Protocol & Scripts.  
• Oversee vendor qualification assessments and documentation reviews and approvals to ensure third-party systems align with client validation expectations and regulatory standards. 
• Guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5  
• Conduct risk assessments for computerized systems to identify potential gaps in compliance. Review and identify validation deviations and resolve deviations with appropriate corrective/ preventive actions  
• Develop validation strategy and documentation for cloud-based and SaaS GxP systems, ensuring alignment with client IT controls, cybersecurity policies, and data residency requirements. 
• Develop Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance.  
• Stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts.   
• Provide guidance on data integrity principles and ensure alignment with industry standards.  
• Responsible for other duties and projects assigned 

Qualifications:

Required:

• Bachelor's degree in engineering or scientific discipline.  
• IT Quality Assurance professional with a minimum of 5 years of experience with computerized system validation in Life Sciences industry.  
• Experience validating systems such as LIMS, MES, ERP, QMS, or other laboratory/manufacturing software. 
• Proficiency in authoring, reviewing and executing computer validation documentation (URS, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR). 
• Proven track record of working with regulatory and industry frameworks such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC. 
• Ability to work independently and collaboratively across cross-functional teams. 
• Familiarity with audit readiness and experience supporting regulatory inspections or internal audits. 

Preferred:

• Master’s degree in a relevant discipline.  
• Experience with QMS software implementation is highly desirable. 
• Experience working with SaaS systems, data integrity programs, and GxP cloud validation strategies. 
• Familiarity and/or industry certification with tools like ARISg database, QMS software platforms such as MasterControl, Veeva Vault QualityDocs/Quality Suite/Safety, paperless validation tools (Kneat, ValGenesis, or similar). 
• Experience of working for US/EU based clients is a plus