MES PAS-X platform CSV Lead
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Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Position Overview
We are seeking an experienced Computer System Validation (CSV) Lead with proven expertise leading and executing validation activities for MES PAS-X implementations in regulated environments. This role will be responsible for planning coordinating and delivering end-to-end validation deliverables to ensure compliance with GxP FDA and global regulatory standards.
Key Responsibilities
Lead CSV strategy planning and execution for MES PAS-X implementation projects.
Ensure compliance with GAMP 5 21 CFR Part 11 Annex 11 and data integrity guidelines.
Coordinate cross-functional teams (IT Quality Manufacturing Vendors).
Oversee testing execution deviation management and defect resolution.
Review system configuration and ensure validation alignment with system design.
Provide audit/inspection readiness support.
Mentor junior validation resources and enforce documentation standards.
Required Qualifications
Bachelors degree in Engineering Computer Science Life Sciences or related field.
7 years of Computer System Validation experience in regulated industries.
3 years leading CSV activities for enterprise-level systems.
Hands-on experience validating MES PAS-X platforms.
Strong knowledge of validation lifecycle methodology and regulatory expectations.
Demonstrated experience authoring and reviewing validation documentation.
Excellent communication leadership and stakeholder management skills.
Preferred Qualifications
Experience with manufacturing execution systems in biologics or pharma production.
Prior involvement in global or multi-site implementations.
Familiarity with SDLC methodologies (Waterfall Agile Hybrid).
Audit or regulatory inspection participation experience.
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
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
