The Validation Engineer is responsible for overseeing all aspects of validation engineering, focusing primarily on IQ, OQ, PQ activities to ensure successful validation outcomes that surpass customer expectations. This role includes managing validation projects, analyzing statistical data for performance indicators, and conducting risk assessments to ensure compliance with medical validation and regulatory standards. Core areas of responsibility include equipment, facility, utility, process, method, sterilization, software validation, statistical process control, project management, and KPI development. The role involves both internal collaboration and external communication to guarantee customer satisfaction, timely validation completions, and alignment with company objectives.
Key Responsibilities:
Collaborate across departments to define validation project scope, responsibilities, timelines, and goals.
Partner with Manufacturing, Quality, and Regulatory teams to design validation processes that meet customer-specific requirements, creating SOPs, protocols, and work instructions.
Manage the validation master list to support required qualifications. Perform qualifications for processes, methods, software, and products based on customer-specific validation protocols.
Ensure compliance with FDA and medical regulatory standards throughout project development and validation practices.
Create, streamline, and manage validation project steps to ensure clarity and conciseness, providing regular status updates to internal and external stakeholders.
Coordinate validation changes with all relevant departments and customers, ensuring software lifecycle and validation plans are up-to-date.
Develop and circulate protocols, SOPs, and work instructions, securing necessary approvals from management and stakeholders.
Support product development by providing validation testing input and output. Identify risks in validation projects that could impact design, manufacturing, or regulatory compliance.
Assist in the transfer of projects from R&D to manufacturing, analyzing part measurements for design of experiments (DOE) and supporting validation of manufacturing procedures, tooling, and fixtures.
Provide production support by validating improvements to manufacturing processes and equipment, and generating or modifying associated documentation.
Assist with the qualification and requalification of sterilization processes.
Develop and update FMEA documentation to support changes to validated products and processes.
Qualifications and Skills:
A minimum of a two-year degree in a relevant field is required; a bachelor's degree or applicable certifications are preferred.
At least three years of experience in manufacturing with a focus on project coordination and IQ/OQ/PQ responsibilities, preferably within a medical device (FDA 21 CFR 820 or ISO 13485:2016) or pharmaceutical (21 CFR 210-211) environment.
Strong understanding of project coordination, validation methodologies (IQ/OQ/PQ), and statistical process control.
Experience in Six Sigma, process capability statistics, and AQL, with a background in FDA-regulated industries preferred.