IR
Quality Validation Engineer/Validation Specialist
Integrated Resources, Inc
🇺🇸 United States
On-site
Mid level
4 weeks ago
- Regulatory Compliance
- CAPA
- GxP
- GMP
4 weeks ago
Location: Swiftwater, PA
Duration: 12 Months+ Possible Extension
Schedule: Monday - Friday; 9 AM - 5 PM
Pay Range: $80-$90/hr
Experience: 6-9 Years
Description:
- We are seeking a highly skilled and experienced quality and validation professional to join a dynamic team within a fast-paced, regulated life sciences manufacturing environment.
- This role is central to ensuring that all manufacturing processes, equipment, facilities, and systems meet the highest standards of quality, compliance, and regulatory integrity.
- The ideal candidate brings deep expertise in quality systems, validation methodologies, and regulatory frameworks, and thrives in a collaborative, cross-functional setting where precision, accountability, and continuous improvement are paramount.
- 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
Quality Validation Engineer/Validation Specialist · Integrated Resources, Inc