Job Summary: We are seeking an experienced, motivated, and detail-oriented Validation Consultant to join our on-site team in Wichita. The Validation Consultant is responsible for planning, executing, and documenting validation and qualification activities for computerized systems, laboratory systems, manufacturing systems, infrastructure, and regulated processes within life sciences environments. This role works closely with Quality, IT, Engineering, Manufacturing, and business stakeholders to ensure systems are implemented and maintained in compliance with applicable regulatory requirements, including FDA 21 CFR Part 11, GxP, GAMP 5, and other global regulatory standards. The Validation Consultant provides technical and compliance expertise throughout the system lifecycle, from requirements gathering and risk assessment through testing, deployment, and ongoing change management.
- Work on-site at ATG offices or Client offices or facilities on a daily basis
- This may involve a commute of up to 70 miles for extended periods of time
Lead validation and qualification activities for computerized systems, applications, equipment, and infrastructure supporting regulated operations.
Develop and execute validation lifecycle deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
Apply risk-based validation methodologies consistent with GAMP 5, FDA Computer Software Assurance (CSA), and industry best practices.
Facilitate requirements gathering sessions with business, quality, engineering, laboratory, and IT stakeholders.
Review system design documentation to ensure compliance, data integrity, and validation requirements are appropriately addressed.
Author, review, and execute validation test protocols and document test results, deviations, investigations, and corrective actions.
Support implementation and validation of enterprise and manufacturing technologies, including MES, LIMS, ELN, ERP, SCADA, historian, automation, and laboratory systems.
Assess and document system impacts related to change controls, software updates, infrastructure modifications, and periodic reviews.
Support regulatory inspections, internal audits, client audits, and quality assurance reviews by providing validation documentation and compliance evidence.
Collaborate with project teams to develop validation strategies, schedules, and resource plans.
Ensure compliance with applicable regulations and standards including FDA, EU GMP Annex 11, GAMP 5, WHO, MHRA, and other relevant guidance. Ensure software and computer systems meet quality, safety, and regulatory standards.
Identify validation risks and develop mitigation strategies to support successful project delivery.
Participate in client-facing meetings, workshops, assessments, and strategic consulting engagements.
Understand and develop (SDLC) system/software development lifecycle and technical validation documentation. Execute validation testing where appropriate for IT and OT systems.
Produce or maintain accurate and up-to-date documentation for all IT and OT systems, including user manuals, standard operating procedures, work instructions, and validation protocols.
Provide advice/consultation on validation documentation and system/user requirements to achieve the best possible testing outcomes.
Think critically on test structures/design and ensure all client requirements are verified during validation.
Have attention to detail and apply patience when producing or reviewing documentation to identify and fix errors.
Put complex information into clear, concise, and accessible content/format for the intended audience. Ability to review, edit and proofread content for accuracy, clarity, and consistency.
Research and gather information on systems/projects to fully understand operational function and use case. Includes working with SMEs and other teams to research and collect information needed for accurate documentation.
Determine and analyze the needs of end users to ensure that all documentation and requirements are clear and tailored to the system.
Learn and understand complex systems and topics quickly.
Perform risk assessments on various systems
