Quality Validation Engineer

Katalyst CRO; Harrisburg (Dauphin County); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Harrisburg, PA seeks a senior Quality Validation and Compliance professional with 6-9 years in regulated pharma manufacturing. Lead CAPA investigations, drive QSR/GxP compliance, and support validation of equipment, processes, facilities, and computerized systems.

Strong cross-functional collaboration with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs is essential. Candidate will manage multiple projects, maintain rigorous documentation, and deliver

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline required; Master's preferred.
• 6-9 years in pharma/biopharma or regulated manufacturing environments.
• Strong background in quality validation, quality systems, and regulatory compliance.
• Experience leading CAPA investigations and activities.
• Knowledge of QSR, GxP, FDA, and industry best practices.
• Experience supporting validation activities (equipment, process, facility, computerized systems, documentation).
• Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
• Proven cross-functional collaboration with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Strong analytical and problem-solving skills with attention to detail.
• Ability to manage multiple projects with aggressive timelines.
• Excellent verbal and written communication; independent in fast-paced environments.

Skills

Quality validation

CAPA management

Regulatory knowledge

Cross-functional collaboration

Project management

Technical documentation

Analytical skills

Attention to detail

Education

Bachelor's in Engineering or Life Sciences

Master's degree preferred

Tools

Computerized systems validation

Documentation review tools

Job description

• 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.
• Quality Validation & Compliance.
• CAPA Management.
• Regulatory Knowledge (FDA, GMP, GxP, QSR).
• Cross-Functional Collaboration.
• Project Management.
• Technical Documentation & Reporting.
• Continuous Improvement & Quality Excellence.

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.
• Quality Validation & Compliance.
• CAPA Management.
• Regulatory Knowledge (FDA, GMP, GxP, QSR).
• Cross-Functional Collaboration.
• Project Management.
• Technical Documentation & Reporting.
• Continuous Improvement & Quality Excellence.

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.