Validation Engineer - Katalyst Healthcares & Life Sciences

• Conduct Computer System Validation (CSV) for pharmaceutical systems to ensure they comply with FDA regulations and industry standards (e.g., GAMP 5).

• Lead and execute Equipment Validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for pharmaceutical equipment.

• Perform Automation Validation for automated systems, ensuring all processes are validated in accordance with regulatory requirements and company protocols.

• Develop and review validation documentation, including protocols, reports, SOPs, and work instructions.

• Collaborate with cross-functional teams, including manufacturing, quality assurance, and engineering, to support validation efforts.

• Ensure timely and successful completion of validation projects, including risk assessments and impact analysis for changes or new system implementations.

• Conduct root cause analysis and develop corrective actions for equipment and system deviations during validation processes.

• Provide technical expertise in the validation of new equipment, facilities, and processes, ensuring they meet regulatory compliance requirements.

• Maintain knowledge of industry trends, regulatory updates, and new technologies related to validation practices in the pharmaceutical industry.

Requirements:

• Bachelor's degree in engineering, Life Sciences, or a related field.

• 5+ years of experience as a Validation Engineer in the pharmaceutical or biopharmaceutical industry.

• Expertise in Computer System Validation (CSV) with knowledge of GAMP 5, 21 CFR Part 11, and other relevant guidelines.

• Proven experience with Equipment Validation (IQ/OQ/PQ) in a pharmaceutical manufacturing environment.

• Strong background in Automation Validation for automated systems in pharma.

• Familiarity with FDA regulations and industry standards for validation, including cGMP and other quality compliance frameworks.

• Excellent project management, problem-solving, and organizational skills.

• Strong interpersonal and communication skills with the ability to work effectively in a collaborative environment.

• Ability to work onsite in North Carolina.