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Validation Engineer
Katalyst Healthcares & Life Sciences
🇬🇧 United Kingdom | 🇺🇸 United States
On-site
Mid level
1 week ago
- CAPA
- Minitab
1 week ago
Not enough detail in this posting to match
We are seeking an experienced Validation Engineer to support validation activities, quality systems, process improvements, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience developing and executing validation protocols, working with FDA and ISO requirements, conducting root cause analysis, and supporting quality and compliance initiatives.
Roles and Responsibilities:
- Develop, review, and execute IQ/OQ/PQ validation protocols and reports for manufacturing processes, equipment, and software.
- Support process validation, equipment qualification, and verification & validation (V&V) activities.
- Review validation documentation and identify compliance gaps or deviations.
- Support investigation and resolution of validation-related issues, including CAPA and corrective actions.
- Perform root cause analysis (RCA) and support implementation of effective corrective and preventive actions.
- Support FDA inspection readiness and ongoing quality system activities.
- Ensure validation activities comply with applicable FDA regulations and ISO standards.
- Participate in process improvement and continuous improvement initiatives.
- Apply statistical methods and data analysis to evaluate process performance and validation results.
- Use tools such as Minitab for statistical analysis, including interpretation of P-values and other statistical measures.
- Prepare and maintain validation protocols, reports, risk assessments, and supporting documentation.
- Collaborate with Quality, Engineering, Manufacturing, R&D, and other cross-functional teams to manage validation projects.
- Work directly with customers and internal stakeholders to understand validation requirements and project expectations.
- Support new product development activities and ensure appropriate validation requirements are incorporated.
- Maintain accurate and compliant validation records in accordance with company procedures and regulatory requirements.
- Bachelor's degree in engineering, Science, or a related technical discipline.
- Degrees in areas such as Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, Manufacturing Engineering, or Life Sciences are preferred.
- 3–5 years of validation experience in a regulated industry, preferably medical devices, pharmaceuticals, biotechnology, or other highly regulated manufacturing environments.
- Hands-on experience with IQ/OQ/PQ and process/equipment validation.
Validation Engineer · Katalyst Healthcares & Life Sciences