Validation Engineer

S & V Tek Systems; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

S & V Tek Systems LLC is a leading provider of business and technology services, focused on advancing clients’ transformation initiatives. The role covers leading process validations for single-use medical devices, developing validation protocols, and supporting audit readiness and remediation efforts.

You will apply Lean Six Sigma techniques to optimize validation workflows, support CQV activities for warehouse spaces, and contribute to regulatory review-ready documentation.

Qualifications

• Lead and execute Process Validations and Test Method Validations for single use medical devices.
• Develop validation protocols, define critical parameters, execute validation studies, analyze results, and author final validation reports
• Support validation activities including documentation updates, change control and remediation-led updates
• Apply Lean and Six Sigma techniques including process flow mapping, VSM, time-motion studies to refine warehousing and validation processes

Responsibilities

• Lead and execute Process Validations and Test Method Validations for single use medical devices.
• Develop validation protocols, define critical parameters, execute validation studies, analyze results, and author final validation reports
• Support validation activities including documentation updates, change controls, and remediation-driven updates
• Support manufacturing lines during audits and actively participate in audit remediation efforts
• Conduct root cause analysis when validations fail and define corrective actions
• Participate in installation, testing, and validation of automation technologies deployed to support material movement and distribution

Skills

Process validations

Test method validations

Root cause analysis

Lean Six Sigma

Validation reports

Tools

IQ/OQ/PQ protocols

ASRS

AGV

AMR technologies

Job description

Summary: S & V Tek Systems LLC is a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. What makes us different isn''t a tagline; it''s the way we work. We don''t forward resumes and hope for the best. We take the time to understand where a professional like you are headed and only reach out when we genuinely believe there''s a fit worth exploring. I came across your profile, and something stood out.

Responsibilities

• Lead and execute Process Validations and Test Method Validations for single use medical devices.
• Develop validation protocols, define critical parameters, execute validation studies, analyze results, and author final validation reports
• Support visual inspection and mechanical testing (e.g., tensile testing) as part of validation activities.
• Manage and update validation documentation, including change controls, change orders, and documentation updates
• Support approximately 10 validation packages, including remediation-driven updates
• Support manufacturing lines during audits and actively participate in audit remediation efforts
• Conduct root cause analysis when validations fail; identify true root cause and define corrective actions1. Participate in the installation, functional testing, and validation of ASRS, AGV, and AMR technologies deployed to automate material movement and support high-throughput pharmaceutical distribution within the new facility.
• Apply Lean and Six Sigma techniques including process flow mapping, VSM, time-motion studies, and resource utilization analysis to refine warehouse layout and remove throughput bottlenecks before operations officially launched
• Deploy Lean and Six Sigma techniques on the warehouse floor running value stream mapping sessions, time study and workforce utilization studies to streamline inventory movement and reduce waste in daily operations.Design, Plan and executed CQV programs for warehouse spaces including temperature-controlled storage areas, staging zones, and material handling systems, authoring and running IQ/OQ/PQ protocols and compiling validation packages for regulatory review.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.