Systems and Equipment Quality Engineer required for QA Department
QA/Test
Machine translation — original language: Hebrew.Show original
Your tasks
Systems and Equipment Quality Engineer responsible for ensuring compliance with regulatory requirements (GMP, FDA, EU Annex 15, etc.) regarding infrastructure, process equipment, controlled systems, and validation and qualification processes for equipment and systems.
Requirements
- Bachelor's degree in Engineering (Chemistry/Mechanical/Biotechnology/Quality or relevant).
- At least 2–1 years of experience in equipment/systems quality assurance in a GMP environment.
- Familiarity with writing validations for equipment and systems (IQ/OQ/PQ).
- Familiarity with relevant regulatory requirements: GMP, Annex 15, GAMP, 21 CFR Part 11.
- Experience in supporting engineering projects, reviewing technical documents, and change control.
- Experience in investigating deviations, writing CAPA, and participating in audits.
- High level of English (speaking, reading, and writing).
- Ability to work independently, systemic thinking, and good interpersonal skills.