Quality Validation Engineer

Katalyst-Healthcares-; Harrisburg (Dauphin County); On-site; USD 110,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC in the United States is seeking a seasoned Quality/Validation professional to lead CAPA investigations and drive compliance in pharma manufacturing. You will apply your expertise in GxP, QSR, and regulatory requirements to ensure validated processes and robust quality systems across projects.

Ideal candidates have 6–9 years in regulated manufacturing, strong analytical skills, and the ability to manage multiple initiatives with tight timelines, collaborating with

Qualifications

• 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.

Skills

CAPA management

Quality validation

Regulatory compliance

QSR/GxP knowledge

Risk assessment

Cross-functional collaboration

Project management

Documentation & reporting

Analytical skills

Independent decision making

Education

Bachelor's degree in Engineering/Life Sciences

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.