Syncade MES CSV Specialist | GMP/GxP Validation

Inteldot; Manatí (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Inteldot is seeking an experienced Computer System Validation Specialist to support validation activities for the Syncade MES within a regulated pharmaceutical manufacturing environment. The role emphasizes IQ/OQ/PQ/UAT, test script execution, and cross‑functional collaboration across Manufacturing, IT, and Quality teams.

The candidate should have at least 3 years in CSV/MES validation, strong documentation skills, and familiarity with risk-based validation and change control.

Qualifications

• 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.

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.

Skills

Computer system validation

GxP knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences

Tools

Syncade MES

Test script development

Job description

Inteldot is seeking an experienced Computer System Validation Specialist to support validation activities for the Syncade MES within a regulated pharmaceutical manufacturing environment. The role emphasizes IQ/OQ/PQ/UAT, test script execution, and cross‑functional collaboration across Manufacturing, IT, and Quality teams.

The candidate should have at least 3 years in CSV/MES validation, strong documentation skills, and familiarity with risk-based validation and change control.