Inteldot has over 14 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.

We are seeking an experienced MES/CSV Specialist with a strong background in Computer System Validation (CSV) activities, specifically within Syncade MES environments. The successful candidate will play a key role in ensuring compliance with regulatory requirements while supporting validation deliverables and lifecycle management for MES systems.

Key Responsibilities

Execute Computer System Validation (CSV) activities for Syncade MES, including IQ, OQ, PQ, and validation documentation. Prepare, review, and approve CSV deliverables (URS, FS, DS, RA, VMP, Validation Protocols, Summary Reports). Support 21 CFR Part 11 and Data Integrity compliance initiatives. Collaborate with cross-functional teams including QA, IT, Manufacturing, and Engineering to support MES projects. Participate in audits and inspections, ensuring validation activities align with regulatory expectations and client SOPs. Provide onsite support for troubleshooting, system updates, and enhancements related to Syncade MES.

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or related field. 5+ years of experience in Computer System Validation (CSV) within regulated industries (pharma/biotech). Hands-on experience with Syncade MES validation and implementation. Ability to work onsite in North Carolina (no remote option).