CSV Specialist – Syncade MES

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in validation efforts for the Syncade MES, which includes new implementations, system enhancements, upgrades, and modifications.

• Create, review, and execute validation documentation in line with relevant procedures and regulatory standards.

• Prepare and/or conduct IQ, OQ, PQ, UAT, and regression testing activities as required.

• Develop and implement test scripts while documenting test results, deviations, and exceptions.

• Aid in gathering requirements and formulating User Requirements Specifications (URS), Functional Specifications, and other validation deliverables.

• Ensure traceability is maintained between user requirements, functional specifications, risk assessments, and test cases.

• Contribute to risk assessments and the development of validation strategies for Syncade-related systems and processes.

• Investigate and document any validation discrepancies, deviations, and testing challenges.

• Assist in change control processes related to modifications and enhancements of the Syncade system.

• Work collaboratively with Manufacturing, Automation, IT, Quality, Engineering, and other cross-functional teams.

• Ensure that validation documentation is comprehensive, precise, and adheres to applicable GxP, GMP, and data integrity standards.

• Engage in validation planning, status meetings, execution activities, and project reviews.

• Support audits and inspections by supplying necessary validation documentation and technical information.

⛳️ Requirements

• At least 3 years of experience in computer system validation, MES validation, or validation of computerized systems in a regulated setting.

• Practical experience with MES validation or implementation.

• Background in a GMP/GxP-regulated pharmaceutical, biotechnology, or manufacturing environment.

• Understanding of computer system validation principles and relevant regulatory expectations.

• Experience in developing and executing validation test scripts and documenting the outcomes.

• Familiarity with risk-based validation methodologies and change control procedures.

• Excellent technical writing and documentation skills.

• Capability to work efficiently with cross-functional teams and communicate with both technical and business stakeholders.

• Experience with Syncade system configuration, integration, or troubleshooting.

• Knowledge of MES functionalities related to manufacturing, electronic batch records, materials, equipment, or production processes.

• Familiarity with 21 CFR Part 11, data integrity principles, and relevant GxP requirements.

• Understanding of GAMP 5 and risk-based computerized system validation methodologies.

• Experience supporting system upgrades, remediation, or continuous improvement initiatives.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Retirement savings plans with company matching.

• Opportunities for professional development and continuous learning.

• Flexible work arrangements and a supportive work environment.