What are the responsibilities and job description for the Quality Validation Engineer position at Katalyst CRO?
Qualifications & Experience
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
- 6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
- Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
- Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
- Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
- Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
- Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
- Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
- Strong analytical and problem-solving skills with exceptional attention to detail.
- Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
- Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
- Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.
- Quality Validation & Compliance.
- CAPA Management.
- Regulatory Knowledge (FDA, GMP, GxP, QSR).
- Risk Assessment & Root Cause Analysis.
- Cross-Functional Collaboration.
- Project Management.
- Technical Documentation & Reporting.
- Continuous Improvement & Quality Excellence.
- 10 years of experience in a Quality/Validation role.
- Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
- Extensive CAPA experience.
- Extensive Quality Systems Experience.
- Extensive experience in high-speed aseptic filling operations and sterile manufacturing environments.