Quality Validation Engineer
Location: Swiftwater, PA (Onsite)
JD:
The jd is attached. Candidates MUST HAVE:
- 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.
Qualifications & Experience:
Bachelor degree in Engineering, Life Sciences, or a related technical discipline required; Master 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
Navnish kumar
Sr. IT Technical Recruiter
Stellent IT Phone:
Email: navnish
Gtalk: navnishom
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