Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 Month(s)
Skills
LIMS
MES
Pharmaceutical Industry
Manufacturing
Cloud Computing
GxP
Historian
POMS
MDM
IT/OT
Computerized System Validation
Validation
Regulatory Compliance
CSV
Computer System Validation
convergence
BMS/DCS/PCS
Job Details
We are seeking an experienced and highly motivated CSV Implementation Lead to drive the successful deployment and integration of enterprise systems including Dynamics 365, LIMS, POMS, MES, and other automation and data management platforms at a major life sciences/biotech site in the Raleigh, NC area. This is a 100% onsite role with a strong emphasis on leadership, mentoring, and capability-building of internal teams, reporting directly to the CSV/QA Manager.
Required Skills & Qualifications:
- Minimum 10+ years of experience in IT/OT systems within the life sciences, biotech, or pharmaceutical industry.
- Proven track record in implementing LIMS, MES, ERP (preferably D365), and automation systems in a regulated (GxP) environment.
- Strong experience with CSV, data integrity, and compliance requirements.
- Deep understanding of IT/OT convergence, system integration principles, and digital manufacturing ecosystems.
- Prior exposure to Data Historian, POMS, BMS/DCS/PCS, and Cloud platforms in manufacturing.
- Experience in setting up and leading Master Data Governance and MDM frameworks.
- Strong interpersonal and leadership skills, with the ability to influence and mentor cross-functional teams.
- Excellent communication, documentation, and stakeholder management skills.
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