Process Engineering Lead

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

• Develop and implement validation protocols (IQ/OQ/PQ) for sterile processes and equipment.
• Lead validation activities for new systems and modifications, ensuring readiness for scale-up.
• Apply medical-grade validation expertise to align with regulatory standards (FDA, ISO 13485, GMP).

2. Documentation & Regulatory Compliance

• Create and maintain risk assessments, validation plans, and SOPs in accordance with industry standards.
• Collaborate with Quality, R&D, and Regulatory Affairs to ensure all validation practices support compliance goals.
• Support audits and inspections with high-quality documentation and technical clarity.

3. Process Optimization & Risk Mitigation

• Analyze validation outcomes to drive process efficiency and robustness.
• Identify deviations and lead corrective/preventive actions (CAPA).
• Innovate and improve validation approaches using data-driven methods.

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

• Be actively involved in qualification activities, system testing, and troubleshooting.
• Collaborate with engineering teams to integrate validation throughout the product lifecycle.
• Bridge R&D validation efforts with scalable manufacturing solutions.

5. Cross-Functional Collaboration

• Work with multidisciplinary teams to ensure integrated, compliant validation strategies.
• Contribute expertise in sterility assurance, including CIP/SIP system validation.
• 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.