CSV Specialist – Syncade MES

We are seeking an experienced Computer System Validation Specialist to support validation and qualification activities associated with the Syncade Manufacturing Execution System (MES) within a regulated pharmaceutical manufacturing environment. The ideal candidate will have a strong understanding of computer system validation (CSV), GxP requirements, and manufacturing systems, with hands-on experience supporting validation, implementation, testing, and documentation.

Key Responsibilities

• Support validation activities for the Syncade MES, including new implementations, system enhancements, upgrades, and changes.
• Develop, review, and execute validation documentation in accordance with applicable procedures and regulatory requirements.
• Prepare and/or execute IQ, OQ, PQ, UAT, and regression testing activities as applicable.
• Develop and execute test scripts and document test results, deviations, and exceptions.
• Support requirements gathering and development of User Requirements Specifications (URS), Functional Specifications, and other validation deliverables.
• Ensure traceability between user requirements, functional requirements, risk assessments, and test cases.
• Support risk assessments and validation strategy development for Syncade-related systems and processes.
• Investigate and document validation discrepancies, deviations, and testing issues.
• Support change control activities associated with Syncade system modifications and enhancements.
• Collaborate with Manufacturing, Automation, IT, Quality, Engineering, and other cross-functional teams.
• Ensure validation documentation is complete, accurate, and compliant with applicable GxP, GMP, and data integrity requirements.
• Participate in validation planning, status meetings, execution activities, and project reviews.
• Support audits and inspections by providing validation documentation and technical information as required.

• Minimum of 3 years of experience in computer system validation, MES validation, or validation of computerized systems within a regulated environment.
• Hands-on experience with MES validation or implementation.
• Experience working in a GMP/GxP-regulated pharmaceutical, biotechnology, or manufacturing environment.
• Knowledge of computer system validation principles and applicable regulatory expectations.
• Experience developing and executing validation test scripts and documenting results.
• Familiarity with risk-based validation methodologies and change control processes.
• Strong technical writing and documentation skills.
• Ability to work effectively with cross-functional teams and communicate with technical and business stakeholders.

• Experience with Syncade system configuration, integration, or troubleshooting.
• Knowledge of MES functionality related to manufacturing, electronic batch records, materials, equipment, or production processes.
• Experience with 21 CFR Part 11, data integrity principles, and applicable GxP requirements.
• Familiarity with GAMP 5 and risk-based computerized system validation approaches.
• Experience supporting system upgrades, remediation, or continuous improvement initiatives.
• Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related field is preferred.