Overview
Remote
On Site
Full Time
Skills
LIMS
MES
Enterprise Resource Planning
URS
DirectShow
DS
IQ
OQ
PQ
Traceability Matrix
GAMP
Quality Assurance
Auditing
Regulatory Compliance
Computer Science
Life Sciences
Computerized System Validation
Pharmaceutics
Medical Devices
Software Development Methodology
Cloud Computing
SaaS
GxP
Documentation
Communication
Collaboration
Job Details
Responsibilities:
- Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc.
- Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices.
- Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Support system implementations, upgrades, and periodic reviews.
- Collaborate with QA, IT, and business users to drive validation strategy.
- Participate in audits and inspections to demonstrate compliance.
- Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
- 2+ years of hands-on CSV experience in pharma, biotech, or medical device environments.
- Strong working knowledge of GxP, FDA regulations, and SDLC methodologies.
- Experience validating cloud-based or SaaS GxP systems is a plus.
- Excellent documentation, communication, and collaboration skills.
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