Job Description

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.

Requirements:

• 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.