Lead Quality Validation Engineer - CAPA & Compliance

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

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