Quality Validation Engineer at Katalyst CRO in Harrisburg, PA

Job description

• Job Description

Responsibilities

• Leading and managing CAPA investigations and activities.
• Supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
• Collaborating with cross-functional teams including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Managing multiple projects simultaneously while meeting aggressive timelines and strict deadlines.

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.
• 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.
• 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

Required

• Quality validation
• Quality systems
• Regulatory compliance
• CAPA management
• QSR knowledge
• GxP requirements
• Validation activities
• Cross-functional collaboration
• Analytical and problem-solving skills
• Attention to detail
• Project management
• Verbal and written communication

Preferred

• High-speed aseptic filling operations
• Sterile manufacturing environments