Validation Consultant

Validation Consultant

Wichita, Kansas

Contract Duration: 6 Months

Employees will be expected to commute up to 70 miles each way per day to various client sites if working at a long-term client facility. This is not a remote position

We are seeking an experienced, motivated, and detail-oriented Validation Consultant - Computer Systems to join our on-site team in Wichita, specializing in applying risk-based validation practices for computerized systems (CSA/CSV) in a regulated environment. The ideal candidate will have a formal understanding of relevant enterprise class IT/OT systems and technology and a keen interest in quality and regulatory operations in the life sciences industry, including pharmaceuticals, biotechnology, and healthcare.

This role entails validating production, enterprise systems, infrastructure, and laboratory equipment to ensure sustained quality and compliance. As a Validation Consultant you will be responsible for the SDLC and validation execution in client environments to ensure their compliance, particularly in regulated industries such as pharmaceuticals. You will be executing rigorous and risk-based validation protocols, developing test strategies, and managing documentation for system functionality, data integrity, and compliance. At our company, we have a passion for learning and problem-solving. We take those passions, along with our Cybersecurity-First approach, with us to every single client, every single day. We are looking for people with both technical aptitude and the ability to think critically and analyze not just the technology but the people and the processes that surround it as well. You'll be solving technical problems and providing best-in-class solutions to our clients and users to maximize the value of technology in their business.

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

Key Responsibilities:

Work on-site at our 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

Develop relevant SDLC documentation in concert with other vendors, consultants, OEMs, and the client such as the URS, FRS/FDS, Impact Assessments, SDS, HDS, and more as applicable

Develop, execute, and document validation protocols (IQ/OQ/PQ) for computerized systems

Create comprehensive validation plans, testing scripts, and traceability matrix documentation

Conduct validation testing, assess test results, and ensure compliance with regulatory standards

Ensure compliance with 21 CFR Part 11, GAMP 5, EU Annex 11, and any other relevant regulations

Manage the creation, review, and maintenance of validation documentation including reports

Conduct risk assessments and develop mitigation plans to ensure data integrity

Collaborate with Engineering/Automation, IT, QA, Production, and laboratory teams during system implementation or system upgrades

Review systems to ensure they meets validation and regulatory compliance requirements

Verify system functionality, reporting, compliance, security & access controls, data/system backup, etc

Identify opportunities for enhancing processes, workflows, and efficiency

Stay updated on emerging regulations, validation methodologies, and industry trends.

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 strategies

Provide strategic advice on using technology to achieve goals using an understanding of the Oversee or support the implementation of IT/OT solutions tailored to the life sciences sector, including but not limited to laboratory information management systems (LIMS), manufacturing execution systems (MES), manufacturing/filling lines, and enterprise resource planning (ERP) systems from the validation perspective

Produce or maintain accurate and up-to-date documentation for all IT and OT systems, including user manuals, SOPs, and validation protocols

Understand and develop SDLC and technical validation documentation and execute testing where appropriate

Ensure that all IT and OT systems comply with industry regulations and standards, including cGxP, FDA (21 CFR), Annex 11, and ISO

Work collaboratively with cross-functional teams, including R&D, quality assurance, and manufacturing, to deliver IT/OT solutions that meet business needs

Minimum Qualifications:

Bachelor's (BSc/BA) degree in Information Technology, Computer Science, Engineering, or a related field. MSc/MBA in business will be a plus

1-8 years of experience in Computer Systems Validation, preferably within the life sciences industry

Experience with computerized system validation, documentation practices, and data integrity compliance

Strong understanding of validation requirements for computer systems validation/computer software assurance in a GMP, GLP, or GCP environment

Proficiency with validation lifecycle documents, risk management, and software development lifecycle (SDLC)

Knowledge of applicable regulatory standards (e.g., 21 CFR Part 11/Annex 11, GAMP 5)

Strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to work effectively in a team environment

A high degree of proficiency with Microsoft Word and Microsoft Excel

Strong written communication and time management skills

Employees must provide their own means of reliable transportation

BYOD is expected, employees will be required to use a cell phone for work purposes including the installation of work communication tools such as MS Teams or Outlook

Experience with the follow items/areas are a plus but not required:

Experience with Kneat GX or ValGensis

Clean Utilities/Filling experience preferable within the context of Computerized Systems

Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience

Knowledge of enterprise IT systems, including systems such as Active Directory, IAM, ERP, and Operational Technology systems, including but not limited to experience with IIoT, PLCs, HMIs, SCADAs, etc.

21 CFR Part 58

21 CFR Part 210 & 211

ICH E6(R3)