Validation (CSA/CSV) Consultant

Arc Technologies Group, LLC•Wichita, KS

1d•Onsite

About The Position

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. If you consider yourself a motivated and ambitious individual, this will be the job for you. Arc Technologies Group serves companies from growth startups to the Fortune 50 within Life Sciences and Healthcare.

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
Strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to work effectively in a team environment
Must be authorized to work in the United States.
Candidates must be authorized to be employed in the U.S. by any employer.
Must be available to work on-site in Wichita, KS during standard business hours (roughly 8am-5pm, Monday-Friday)
Requires routine sitting, standing, walking, listening and talking
Acute mental and visual attention at all times
Ability to handle multiple projects while managing frequent interruptions

Nice To Haves

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.
Understand or have previous knowledge/experience in using document management systems and/or electronic execution systems with workflow and versioning capabilities.
Operational Technology foundational knowledge, including but not limited to experience with IIoT, PLCs, HMIs, SCADAs, etc.
Familiarity with enterprise IT and OT cybersecurity architecture and/or frameworks
Have the ability to troubleshoot hardware, software, and network problems & to think critically to analyze and remediate root causes
ITIL Framework

Responsibilities

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
Understand client requirements, business objectives & processes, in addition to their technology and systems
Leverage your sales mindset to deepen customer relationships, help 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