CSVMES Specialist
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Job Location:
Charlotte, VT - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
- Bachelors 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).
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI in Puerto Rico.Description:Under general supervision, provides characterization of process ... View more
