Validation Engineer at Katalyst CRO in Warwick, RI

Job description

• We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience with IQ/OQ/PQ, process and equipment validation, verification and validation (V&V), CAPA, root cause analysis, and process improvement. The candidate will collaborate with cross-functional teams and customers to ensure validation activities meet regulatory, quality, and business requirements.

Responsibilities

• Develop, review, and execute IQ, OQ, and PQ validation protocols for processes, equipment, systems, and software.
• Prepare and maintain validation plans, protocols, reports, and supporting documentation.
• Support process validation, equipment qualification, and verification & validation (V&V) activities.
• Review validation documentation and identify compliance gaps, risks, and deficiencies.
• Support CAPA investigations, root cause analysis (RCA), deviations, and corrective actions.
• Identify and implement process improvements to improve quality, reliability, and efficiency.
• Support FDA inspection readiness, audits, and quality system activities.
• Perform statistical analysis of validation and process data using appropriate methods.
• Use Minitab and statistical techniques, including P-value analysis, where applicable.
• Collaborate with Quality, Engineering, Manufacturing, R&D, Operations, and other cross-functional teams.
• Work with customers and internal stakeholders to manage validation projects, requirements, timelines, and deliverables.
• Ensure validation activities comply with FDA regulations, ISO 13485, ISO 14971, and company quality procedures.
• Maintain accurate and complete validation documentation in accordance with GMP/GDP and QMS requirements.

Requirements

• Bachelor's degree in engineering, Science, or a related technical discipline.
• Preferred disciplines include Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering, Manufacturing Engineering, or Life Sciences.
• 3–5 years of validation experience in a regulated industry, preferably medical devices.
• Hands-on experience with IQ/OQ/PQ and process/equipment validation.
• Knowledge of FDA medical device regulations, ISO 13485, and ISO 14971.
• Experience with CAPA, root cause analysis, deviations, and process improvement.
• Experience supporting verification and validation activities.

Skills

Required

• Validation experience (IQ/OQ/PQ)
• Process and equipment validation
• Verification and validation (V&V)
• Statistical analysis
• Minitab
• GMP/GDP and QMS documentation