Validation (CSA/CSV) Consultant

About the role

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.

Responsibilities

• Work on-site at ATG offices or client offices/facilities daily (commute up to 70 miles may be required for extended periods).
• 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.
• 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 system/software development lifecycle (SDLC) and technical validation documentation.
• Execute validation testing 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 optimal testing outcomes.
• Think critically on test structures/design and ensure all client requirements are verified during validation.
• Research and gather information on systems/projects to fully understand operational function and use case, including working with SMEs and other teams.
• Determine and analyze the needs of end users to ensure documentation and requirements are clear and tailored to the system.
• Perform risk assessments on various systems.

Above & Beyond Responsibilities

• Understand client requirements, business objectives, and processes, in addition to their technology and systems.
• Leverage a sales mindset to deepen customer relationships, transform services into comprehensive solutions, and collaborate with the sales team to align goals with outcomes.
• Identify expansion opportunities to drive growth and ensure customer satisfaction through innovative IT/OT, validation, engineering, and quality strategies.
• Support new technology implementation and provide assistance with technical issues, strategic direction, and financial analysis of projects/initiatives.
• Perform critical analysis of existing “People, Process, and Technology” state of clients.
• Work collaboratively with cross-functional teams, including R&D, quality assurance, and manufacturing, to deliver IT/OT solutions that meet business needs.

Requirements

• Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related technical discipline.
• Minimum of 2 years of experience in computerized systems validation (CSV), computer software assurance (CSA), commissioning and qualification (C&Q), or a related validation discipline within the pharmaceutical, biotechnology, medical device, or regulated healthcare industry.
• Strong understanding of FDA 21 CFR Part 11, GxP regulations, data integrity principles, and GAMP 5 guidance.
• Experience developing and executing validation lifecycle documentation including URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation reports.
• Experience supporting validation of GxP systems such as LIMS, MES, ERP, QMS, laboratory instruments, manufacturing execution systems, automation platforms, or cloud-based applications.
• Knowledge of software development lifecycle (SDLC), change management, configuration management, and quality management processes.
• Demonstrated ability to interpret regulatory requirements and translate them into practical validation strategies.
• Strong technical writing, documentation, analytical, and problem-solving skills.
• Excellent verbal and written communication skills with the ability to interact effectively with technical, quality, and business stakeholders.
• Ability to manage multiple projects and priorities in a fast-paced consulting environment.
• Must be authorized to work in the United States (U.S. work visa sponsorship is not available for this role).
• Must be available to work on-site in Wichita, KS during standard business hours (roughly 8am-5pm, Monday-Friday).
• Must provide own reliable transportation for commuting up to 70 miles daily to client sites.
• BYOD (Bring Your Own Device) expected; must use a cell phone for work purposes, including installation of work communication tools such as MS Teams or Outlook.
• Requires routine sitting, standing, walking, listening, and talking with acute mental and visual attention at all times.
• Ability to handle multiple projects while managing frequent interruptions.
• Moderate lifting or moving up to 100 pounds may be required.

Preferred Qualifications

• Experience with FDA Computer Software Assurance (CSA) methodology.
• Knowledge of manufacturing automation platforms, OT systems, and industrial control systems.
• Familiarity with cloud-hosted GxP systems and SaaS validation.
• Previous consulting experience supporting multiple clients and projects.
• Certifications such as ASQ Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), PMP, or relevant validation certifications.
• Experience supporting regulatory inspections and remediation initiatives.
• Experience with document management systems and/or electronic execution systems with workflow and versioning capabilities.
• Operational Technology foundational knowledge, including IIoT, PLCs, HMIs, SCADAs, etc.
• Familiarity with enterprise IT and OT cybersecurity architecture and/or frameworks.
• Ability to troubleshoot hardware, software, and network problems and analyze/remediate root causes.
• ITIL Framework knowledge.

About Us

Arc Technologies Group is a boutique professional services firm focused exclusively on life sciences, including pharmaceutical manufacturing, biotech, CDMO, medical devices, and animal health. We deliver technology that actually works for organizations operating in highly regulated environments. Our team brings deep experience in IT/OT convergence, cybersecurity, digital transformation, and compliance-driven technology solutions across the entire life sciences technology space.

Benefits

• 401K
• Short-term/Long-term disability
• Medical/Dental/Vision may be available
• Opportunities for professional development and career advancement
• Collaborative & high-performance work environment

Arc Technologies Group employees are paid on an hourly basis; this is not a salaried position.