Data Integrity Specialist

• Partner with the IT Computer System Validation Manager and other departments to develop and execute comprehensive Computerized System Validation (CSV) plans for automated equipment, processes, and systems.
• Conduct thorough risk assessments to identify potential data integrity vulnerabilities and ensure compliance with regulations like 21 CFR Part 11.
• Develop and implement robust data integrity assessments and data mappings for new systems, aligning them with established Data Integrity plans and procedures.
• Create clear and concise test scripts to verify that systems meet data integrity requirements, user specifications, and regulatory guidelines.
• Write well-defined Software/Computer Validation Protocols according to client policies and best practices./
• Perform computerized system validations adhering to cGMPs, site procedures, and regulations (FDA, DEA, etc.).
• Coordinate and execute validation activities as outlined in approved protocols, ensuring a smooth and efficient process.
• Analyze test data to make informed recommendations on computer software acceptance or rejection.
• Prepare comprehensive Final Validation Reports following FDA certification principles.
• Advise the IT Computerized System Validation Manager on the adequacy and completeness of validation protocols.
• Provide technical expertise regarding validation plans and protocols, ensuring alignment with Data Integrity requirements and established site procedures.
• Contribute to the development of user and design specifications for relevant systems, ensuring functionality and data integrity.
• Review and approve validation documents for various equipment, processes, and systems used throughout the pharmaceutical manufacturing environment.
• Manage and maintain validation documentation throughout the system lifecycle, ensuring all records are accurate and up-to-date.
• Actively support investigations related to manufacturing, laboratories, facilities, and utilities. Provide an IT perspective on root cause analysis to identify and address potential issues.
• Participate in risk analysis processes for IT-related events requiring immediate resolution, ensuring data integrity and process continuity.
• Maintain accurate and complete records in the Infinity System for audit observations, investigations, change control, and corrective actions (CAPAs).

• Bachelor's degree in Computer Science, Engineering, or a related scientific field (preferred).
• Five (5) years of experience in computerized system validation within the pharmaceutical or biopharmaceutical industry ( strongly preferred).
• Strong understanding of laboratory instruments, pharmaceutical manufacturing processes, and GMP regulations is essential.
• In-depth knowledge of relevant GMP, FDA regulations (21 CFR Part 11) and Data Integrity principles (Risk Assessment, Data Mapping, etc.).
• Proficiency in network communication protocols (TCP/IP).
• Experience with GAMP5 validation methodology is a plus.
• Excellent written and verbal communication skills in English and Spanish are required for effective collaboration.
• Proven ability to revise and create technical documentation in English using MS Office applications.
• Strong analytical and problem-solving skills with a focus on root cause analysis are essential for identifying and resolving data integrity issues.
• Attention to detail and accuracy are paramount in this role.
• Proficiency in computer systems (Microsoft Office) and data collection software (databases) like Infinity and SAP.
• Ability to analyze data, detect deviations, interpret results, and identify inconsistencies.
• Self-motivated, creative, and a team player with a strong work ethic.
• Willingness to work irregular hours, rotative shifts, weekends, and holidays as needed to ensure project deadlines are met.

RCM Technologies