CSV Small-Molecule
We are recruiting for a global pharmaceutical powerhouse seeking an experienced Lead Computer System Validation (CSV) Engineer to join their team! This role is ideal for someone who wants to contribute to high‑impact pharmaceutical operations while working entirely remotely with excellent career development opportunities.
Why This Role Stands Out
Fully Remote Work
Work from anywhere with genuine work-life balance and no commuting.
Highly Competitive Salary
We offer top‑tier compensation to attract the strongest talent in the market.
Exceptional Training and Development
You will have access to leading training programs, certifications, and continuous professional development resources.
About the Role
As the Lead CSV Engineer, you will:
- Lead CSV strategy across small‑molecule R&D, QC laboratories, and manufacturing systems
- Oversee validation lifecycle deliverables, including URS, risk assessments, IQ/OQ/PQ, testing, and reporting
- Ensure compliance with FDA, EMA, GxP, data integrity expectations, and GAMP 5
- Collaborate with Quality, IT, Automation, R&D, and Operations teams
- Serve as the CSV subject matter expert during internal audits and regulatory inspections
- Mentor junior engineers and drive validation best practices
What We're Looking For
- 7+ years of CSV experience within a pharmaceutical environment
- Strong background working with small‑molecule processes, equipment, and digital systems
- Expertise in 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, and GxP system lifecycle
- Experience with LIMS, QMS, MES, DCS/SCADA, or laboratory instrument software
- Excellent communication skills and strong documentation abilities
Preferred Experience
- Previous experience supporting commercial‑scale small‑molecule operations
- Familiarity with cloud‑based GxP systems and modern digital validation tools
Interested in Joining Us?
If you are seeking a role offering flexibility, strong compensation, and outstanding career development, we would welcome your application. Please apply directly or reach out for more information.
FAQs
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