- Professional
- Escritório em Charlotte
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).
