Quality Validation Engineer

We are looking for Quality Validation Engineer for our client in Swiftwater, PA

Job Title: Quality Validation Engineer

Job Location:Swiftwater, PA

Job Type: Contract

Job Overview:

Pay Range: $92.41hr - $97.41hr

Requirement/Must Have:

• 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.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
• Strong 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.

Responsibilities:

• Lead and manage Corrective and Preventive Action (CAPA) investigations and activities.
• Support validation activities, including equipment, process, facility, computerized systems, and documentation review.
• Collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Ensure regulatory compliance within the life sciences industry.
• Perform risk assessment and root cause analysis.
• Manage technical documentation and reporting.
• Drive continuous improvement and quality excellence.

Nice to Have:

• Experience in high-speed aseptic filling operations and sterile manufacturing environments.

Skills:

• 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.

Qualification And Education:

• Bachelor s degree in Engineering, Life Sciences, or a related technical discipline.
• Master s degree preferred.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities