CSV Engineer
Job Description:
We are seeking an experienced Computer Systems Validation (CSV) Engineer with strong communication skills and a true consultant mindset. The ideal candidate will have solid experience in pharma validation environments and hands-on exposure to manufacturing and automation systems.
Requirements:
We are seeking an experienced Computer Systems Validation (CSV) Engineer with strong communication skills and a true consultant mindset. The ideal candidate will have solid experience in pharma validation environments and hands-on exposure to manufacturing and automation systems.
Requirements:
- Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
- 5+ years of experience in CSV/CSA frameworks (GAMP) within the Pharma industry.
- Hands-on experience with SCADA, OSI-PI, Siemens_desigo, Rockwell FactoryTalk Pharma Suite, DeltaV, and MES.
- Experience with system administration and EBR recipe authoring preferred.
- Strong understanding of ISA-95 model (Level 2 & Level 3 required; Level 1 is a plus).
- Knowledge of FDA regulations (21 CFR Part 11), Annex 11, EU GMP Annex 1, GxP practices, and Data Integrity principles.
- Experience performing system and data integrity risk assessments.
