The Quality Validation Engineer is responsible for supporting and leading quality validation, quality systems, CAPA, and regulatory compliance activities within a pharmaceutical or biopharmaceutical manufacturing environment. The role ensures that equipment, processes, facilities, computerized systems, and related documentation meet FDA, GMP, GxP, and QSR requirements.
- 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.
Key Competencies:
- 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
Skills need :
- 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.
- Lead and support validation activities for equipment, processes, facilities, utilities, computerized systems, and related documentation.
- Develop, review, execute, and approve validation protocols and reports.
- Lead CAPA investigations, including root cause analysis, corrective actions, preventive actions, and effectiveness checks.
- Support deviation investigations, change controls, risk assessments, and quality assessments.
- Ensure validation activities comply with FDA, GMP, GxP, QSR, and applicable regulatory requirements.
- Support validation activities for high-speed aseptic filling and sterile manufacturing operations.
- Review and maintain validation documentation and technical reports.
- Collaborate with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs teams.
- Identify and mitigate quality and compliance risks associated with manufacturing and validation activities.
- Manage multiple validation projects and ensure deliverables are completed within established timelines.
- Support regulatory inspections, internal audits, and inspection-readiness activities.
- Provide technical guidance on quality validation and quality system requirements.
- Drive continuous improvement and quality excellence initiatives.
- Communicate project status, risks, issues, and recommendations to cross-functional stakeholders.