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 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 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 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 MES validation and implementation.
- Ability to work onsite in New Jersey (hybrid option).
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What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
