Validation Engineer II - CSV and Compliance Support

🌟 We're Hiring:
Validation Engineer II - CSV and Compliance Support! 🌟

We are seeking a skilled Validation Engineer II to provide critical support in Computer System Validation (CSV) and compliance. The ideal candidate will have a solid background in validation protocols, regulatory requirements, and excellent problem‑solving skills to ensure our systems meet industry standards.

• 🎯 Develop and execute validation plans for computer systems
• 📊 Conduct risk assessments and ensure compliance with regulations
• 🔍 Perform audits and inspections to maintain quality standards
• 🤝 Collaborate with cross‑functional teams to address validation issues
• 📝 Document validation activities and prepare reports for stakeholders
• ⚙️ Provide training on compliance procedures to team members

• ✅ Minimum of 5 years in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.
• ✅ BS or MS in computer science, engineering, life sciences, or related field
• ✅ SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, Delta
  
  V, Manufacturing Execution Systems (MES) Systems administration and E  recipe authoring, software development, PLC
• ✅ Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required
• ✅ ISA-95 (or IEC 62264);
  Level 3 (Manufacturing Operations Management): MES, scheduling, quality, and maintenance management.;
  Level 2 (Batch/Continuous/Discrete Control):
  Supervisory control (SCADA), PLC monitoring.
• ✅ Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices

Ready to make an impact? 🚀 Apply now and join us in ensuring excellence!