CSV/MES Specialist jobs in United States
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Inteldot ยท 1 day ago

CSV/MES Specialist

positionNJ, US
timeFull-time
remoteHybrid
senioritySenior Level
date5+ years exp

Inteldot is a company with over 14 years of experience in the life science industry, seeking an experienced MES/CSV Specialist. The role involves ensuring compliance with regulatory requirements and supporting validation deliverables for MES systems.

Information Technology & Services

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

Qualification

Computer System Validation (CSV)Manufacturing Execution Systems (MES)21 CFR Part 11 complianceData IntegrityEngineering degreeLife Sciences degreeCross-functional collaboration

Required

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)

Company

Inteldot

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Inteldot provides IT Services and IT Consulting.
dateFounded in 2004
location
San Juan, Puerto Rico, PR
people-size11-50 employees
web-link
https://www.inteldot.com/

Funding

Current Stage
Early Stage

Leadership Team

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Reggy Agosto
Founder & CEO
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Company data provided by crunchbase