Process Validation Engineer

Job Title:

Process Validation Engineer

Job Description

The Process Validation Engineer leads validation activities for automation and equipment capital projects, drives process improvements, and ensures new equipment installations and process transfers are fully validated and ready for production in a regulated medical device environment.

Responsibilities

+ Prepare, author, and execute validation documentation to ensure all automated systems and process improvements are validated (IQ/OQ/PQ) and compliant with 21 CFR Part 820 and other applicable standards prior to release to production.

+ Evaluate and define validation strategies that enable quick, robust, and compliant transfer of processes and equipment into production.

+ Maintain Agile documentation related to processes and equipment, including standard operating procedures (SOPs), flow charts, electrical drawings, 2D/3D drawings, equipment parameter lists (CP), and equipment logic programs (LCP).

+ Ensure compliance with FDA Quality System Regulations (QSR) and relevant product-specific regulations and standards (such as IEC and ISO) throughout all validation activities.

+ Drive operational and regulatory excellence by consistently applying best practices in validation and quality engineering.

+ Lead validation activities tied to process changes, including creating, approving, and executing validation protocols from scratch.

+ Support the implementation of new equipment and new or upgraded processes, working closely with R&D and Quality teams in a highly integrated environment.

+ Ensure all changes to equipment and processes meet medical device validation and quality standards and are properly documented.

+ Maintain strong, open communication with cross-functional teams to ensure alignment, timely issue resolution, and clear visibility of project status.

+ Plan and execute full validation life cycles, including URS (User Requirement Specifications), FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), IQ/OQ/PQ (Installation, Operational, and Performance Qualifications), validation protocols and execution, and development of instructional and operating documents and quality handbooks.

+ Assist with automation and equipment capital projects from concept through installation and final validation, ensuring smooth handover to production.

+ Work hands-on with processes and equipment as needed to troubleshoot issues, gather data, and verify performance during validation activities.

+ Champion Lean, Six Sigma, and Design for Manufacturability/Design for Assembly (DFM/DFA) principles across internal and outsourced operations to improve efficiency and quality.

+ Apply Scrum methodology to project work by breaking large projects into milestones and 1-2 week sprints, conducting sprint planning to define short-term deliverables, and participating in regular stand-up meetings (45-60 minutes) to track progress and adjust plans.

+ Complete and sign validation documentation and reports, ensuring accuracy, completeness, and regulatory compliance.

+ Review quality handbooks and requirements to ensure validation activities align with established quality standards and procedures.

Essential Skills

+ Proven experience in medical device validation, with at least 3+ years focused on medical device process validation.

+ Five years of experience working in the medical device field.

+ Strong background in process validation and regulatory compliance within a medical device environment.

+ Hands-on experience with validation activities including URS, FAT, SAT, IQ, OQ, and PQ.

+ Ability to prepare, complete, and interpret complex validation reports and documentation.

+ Good computer skills, including proficiency with Microsoft Word and Excel.

+ Experience working with Agile documentation practices.

+ Familiarity with Scrum methodology in an engineering or validation context.

+ Ability to work effectively with cross-functional teams, including R&D and Quality.

+ Strong attention to detail and commitment to regulatory and quality standards.

Additional

Skills & Qualifications

+ Bachelor's degree in a related field.

+ 3-5 years of relevant work experience in process validation, quality engineering, or a closely related discipline.

+ Experience in medical device quality engineering and process validation.

+ Knowledge of FDA QSR, 21 CFR Part 820, and relevant IEC and ISO standards.

+ Experience applying Lean, Six Sigma, and Design for Manufacturability/Design for Assembly (DFM/DFA) principles.

+ Experience working with Agile documentation tools and practices.

+ Scrum methodology experience, including sprint planning and participation in regular stand-ups.

+ Ability to complete complex reports and documentation, including in Spanish.

+ Strong written and verbal communication skills for collaborating with cross-functional teams.

+ Interest in contributing to innovative, life-saving medical devices in a collaborative, growth-oriented environment where work has direct global impact on patient care.

Work Environment

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