P
Validation & Projects Engineer
·Israel
On-siteFull-timePharmaceutical Manufacturing
Validation & Projects Engineer at a GMP pharmaceutical facility. Execute validation for equipment, processes, and systems; lead engineering projects; integrate new equipment. Requires B.Sc. Engineering, 3+ years pharma validation, excellent English.
Responsibilities
- Execute validation activities for equipment, systems, manufacturing processes, and computerized systems in accordance with GMP, FDA, EMA regulations.
- Lead engineering projects from planning through implementation.
- Lead the integration of new equipment and systems into production environments.
- Collaborate with production, quality, maintenance, regulatory affairs, and other departments.
Requirements
- B.Sc. in Engineering.
- Minimum 3 years' experience in validation execution and project leadership in the pharmaceutical industry under GMP.
- Experience in validation of production equipment (e.g., autoclaves, HVAC systems).
- Excellent English level (written, reading, and spoken).
- Strong ability to write and edit technical documents, protocols, and reports.
- Excellent interpersonal skills, team player, proactive, independent, with strong technical orientation and analytical abilities.
Nice to have
- Experience in validation of manufacturing processes, scale-up, and cleaning processes.
- Experience in cleanroom construction projects.
- Background in aseptic/sterile manufacturing.