Senior Validation Specialist: CAPA & Quality Systems Leader

Katalyst-Healthcares-; San Jose (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC in San Jose, CA, seeks an experienced Quality Validation professional to lead validation activities and CAPA programs in a regulated life sciences environment.

The role requires strong collaboration with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs, plus a track record of meeting strict deadlines in fast-paced settings.

Qualifications

• Experience supporting validation activities across equipment, processes, facilities, and computerized systems.
• Preferred background in high-speed aseptic filling and sterile manufacturing environments.
• Led CAPA investigations and related corrective actions.
• Strong knowledge of QSR, GxP, and industry best practices.
• Collaborates with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.

Responsibilities

• Lead CAPA investigations and drive effective corrective actions.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Prepare technical documentation and risk assessments with attention to detail.

Skills

Quality Validation

CAPA Management

Regulatory Knowledge

Cross-Functional Collaboration

Project Management

Risk Assessment

Communication

Detail Orientation

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree preferred

Job description

Requirements:

• 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.
• 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.
• 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.
• 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.

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.