Title: Quality Validation Engineer / Validation Specialist
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.

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.

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