Quality Validation Engineer

Katalyst-Healthcares-; Swiftwater (Monroe County); On-site; USD 105,000 - 145,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Validation Lead to oversee CAPA investigations, validation activities, and regulatory compliance in a fast-paced life sciences setting. The role emphasizes cross-functional collaboration across Quality, Manufacturing, Engineering, and Regulatory Affairs.

The ideal candidate has a strong background in GxP and QSR, with 6–9 years of regulated manufacturing experience, and excellent communication and documentation skills.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
• 6-9 years of experience in pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
• Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
• Experience leading and managing CAPA investigations and activities.
• Comprehensive knowledge of QSR, GxP, FDA regulations, and industry best practices.
• Experience supporting validation activities across equipment, process, facility, computerized systems, and documentation.
• 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.

Responsibilities

• Lead and manage CAPA investigations and activities.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.

Skills

Quality validation

CAPA management

Regulatory knowledge

Risk assessment

Root cause analysis

Cross-functional collaboration

Project management

Technical documentation

Continuous improvement

Quality systems

Aseptic filling experience

Sterile manufacturing

Communication skills

Attention to detail

Education

Bachelor's degree in Engineering/Life Sciences or related discipline

Master's degree preferred

Job description

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.

Skills need:

• 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.