CSV Specialist – Syncade MES

CINCO Engineering

. Support validation activities for the Syncade MES, including new implementations, system enhancements, upgrades, and changes .

Posted 10/6/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in computer system validation, particularly in MES environments, with a strong focus on regulatory compliance, documentation accuracy, and cross-functional collaboration. Proficient in developing and executing validation test scripts while ensuring adherence to GxP and data integrity standards.

Highest-signal resume keywords

Computer System ValidationMES ValidationGMP/GxP Regulatory ComplianceValidation Test Script DevelopmentRisk-Based Validation Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation DocumentationTest Script ExecutionUser Requirements Specifications (URS)Functional SpecificationsChange Control ProcessesRisk AssessmentsValidation Discrepancy InvestigationSyncade System ConfigurationData Integrity PrinciplesGAMP 5 Familiarity

Soft Skills

Technical WritingCross-Functional Team CollaborationEffective Communication

Tools & Technologies

Syncade MES

Industry Keywords

21 CFR Part 11PharmaceuticalBiotechnologyManufacturingElectronic Batch Records

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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