CSV Specialist – EBR

Inteldot; Manatí (PR); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

Inteldot is seeking an experienced Computer System Validation Specialist to support CSV activities for the Syncade MES in a regulated pharmaceutical setting.

The role covers validation planning, IQ/OQ/PQ/UAT, test script development, risk assessments, change control, and cross-functional collaboration to ensure data integrity and regulatory compliance.

Formación

• 3+ years in computer system validation, MES validation, or CV within a regulated environment.
• Hands-on experience with MES validation or implementation.
• Experience in GMP/GxP-regulated pharmaceutical, biotechnology, or manufacturing setting.
• Familiarity with risk-based validation methodologies and change control processes.
• Strong technical writing and documentation skills.

Responsabilidades

• Support validation activities for Syncade MES, including implementations and upgrades.
• Develop, review, and execute validation documentation per procedures and regulatory requirements.
• Prepare IQ, OQ, PQ, UAT, and regression testing as applicable.
• Develop and execute test scripts; document results, deviations, and exceptions.
• Support requirements gathering; develop URS, Functional Specs, and other validation deliverables.
• Ensure traceability between requirements, risk assessments, and test cases.
• Support risk assessments and validation strategy for Syncade systems.
• Investigate validation discrepancies and testing issues.
• Assist change control tied to Syncade modifications.
• Collaborate with Manufacturing, Automation, IT, Quality, Engineering, and cross-functional teams.
• Maintain complete, accurate validation documentation per GxP, GMP, and data integrity requirements.
• Participate in validation planning, status meetings, execution, and reviews.
• Assist audits and inspections with validation documentation and technical information.

Conocimientos

Technical writing

Cross-functional collaboration

Regulatory compliance

GxP knowledge

Communication

Educación

Bachelor's degree in Engineering or related field

Herramientas

Syncade MES

Documentation management

Descripción del empleo

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative shift (flexible hours to cover business needs)

Position Summary

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.

Required 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.

Preferred Qualifications

• 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.