Process Engineering Lead

2 weeks ago

Tel Aviv, Tel Aviv, Israel GreenOnyx Full time $70,000 - $120,000 per year

An innovative Ag-tech/Food-tech startup is seeking a hands-on Validation Engineer with proven experience in the medical device industry to lead sterility validation strategy, execution, and compliance for cutting-edge systems operating in sterile manufacturing environments.

This is a unique opportunity to shape the validation infrastructure of pioneering technologies in a dynamic, multidisciplinary environment. The ideal candidate is detail-driven, thrives in fast-paced, multidisciplinary teams, and is ready to take a leading role in a global, highly regulated "blue ocean" market.

Location: Tel Aviv.

Definition & Responsibilities

  1. Validation Strategy & Execution

  2. Develop and implement validation protocols (IQ/OQ/PQ) for sterile processes and equipment.

  3. Lead validation activities for new systems and modifications, ensuring readiness for scale-up.

  4. Apply medical-grade validation expertise to align with regulatory standards (FDA, ISO 13485, GMP).

  5. Documentation & Regulatory Compliance

  6. Create and maintain risk assessments, validation plans, and SOPs in accordance with industry standards.

  7. Collaborate with Quality, R&D, and Regulatory Affairs to ensure all validation practices support compliance goals.

  8. Support audits and inspections with high-quality documentation and technical clarity.

  9. Process Optimization & Risk Mitigation

  10. Analyze validation outcomes to drive process efficiency and robustness.

  11. Identify deviations and lead corrective/preventive actions (CAPA).

  12. Innovate and improve validation approaches using data-driven methods.

  13. Hands-On Engagement in R&D and Production

  14. Be actively involved in qualification activities, system testing, and troubleshooting.

  15. Collaborate with engineering teams to integrate validation throughout the product lifecycle.

  16. Bridge R&D validation efforts with scalable manufacturing solutions.

  17. Cross-Functional Collaboration

  18. Work with multidisciplinary teams to ensure integrated, compliant validation strategies.

  19. Contribute expertise in sterility assurance, including CIP/SIP system validation.
  20. Ensure validation aligns with quality and product development timelines.

Requirements

  • B.Sc. in Engineering (Chemical, Mechanical, Biomedical, or related field).
  • Minimum 3 years of validation experience in the medical device, pharmaceutical, or sterile manufacturing sector.
  • Deep familiarity with FDA regulations, ISO 13485, GMP, and sterility validation standards.
  • Proficient in generating validation documentation: PFDs, P&IDs, SOPs, and risk assessments.
  • Hands-on knowledge of CIP/SIP validation, equipment qualification, and sterility testing.
  • Skilled in using Excel or equivalent tools for analysis and reporting.
  • Excellent problem-solving, communication, and team collaboration skills.
  • Fluent in technical English, both written and spoken.

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