KH
Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
3 weeks ago
- CAPA
- Minitab
- GMP
3 weeks ago
Job summary
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 andequipment 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.
Roles & 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.
- 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 processimprovement.
- Experience supporting verification and validation activities.
Validation Engineer · Katalyst Healthcares & Life Sciences