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.
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