Katalyst Healthcares and Life Sciences
Responsibilities:
- 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.
- 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.