Validation Engineer (Sterility & Cleaning Processes)

GreenOnyx, an innovative Ag-tech/Food-tech company, is seeking a hands-on Validation Engineer to join our Microbiology team, leading validation and ensuring sterility in our smart farm systems. This position requires strong engineering expertise, specifically from medical devices or pharmaceutical industries, and involves actively constructing and validating experimental setups to ensure achieving and maintaining sterile conditions through proper implementation of CIP/SIP processes. Location: Tel Aviv

Role & Responsibilities:

Validation Leadership:

• Develop and implement robust validation strategies and protocols (IQ, OQ, PQ) specifically for sterility and cleaning processes.
• Carry out practical validations tests through the scientific method.
• Hands-on assembly and constructions experimental setups.
• Ensure compliance with industry standards (FDA, ISO 13485, GMP).

Documentation & Regulatory Compliance:

• Prepare comprehensive validation documentation, including detailed reports, SOPs, and risk assessments.
• Work closely with Quality Assurance and Regulatory teams to ensure full compliance.
• Support audits and inspections with accurate validation data and documentation.

Process Evaluation & Optimization:

• Analyze validation outcomes to identify and implement process improvements and robustness.
• Conduct deviation investigations and implement corrective actions promptly.
• Enhance validation techniques and methodologies continuously.

Hands-On Engineering & Validation:

• Collaborate closely with mechanical, automation, and process teams, integrating validation into system development.
• Ensure smooth transition from R&D to full production scale validation.

Collaboration & Cross-Functional Engagement:

• Coordinate with multidisciplinary teams, providing expertise in sterility assurance.
• Contribute actively to development optimization and implementation of CIP (Clean-In-Place) and SIP (Sterilization-In-Place) processes.
• Mentor and guide team members on validation best practices.

Required Skills & Qualifications:

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or related fields).
• Minimum of 3 years hands-on experience in validation engineering within medical devices, pharmaceuticals, or sterile manufacturing.
• In-depth knowledge of FDA, ISO 13485, GMP, and validation of sterile environments.
• Expertise in creating validation documentation (PFDs, P&IDs, SOPs).
• Proficient with Excel for validation data analysis.
• Excellent problem-solving skills and ability to work across various disciplines.
• Fluent in English (technical documentation and verbal communication).
• Willingness to acquire a general biological background and implement newly acquired methods in day to day R&D operations.

Preferred Qualifications:

• Familiarity with automated sterility systems, sensors, and data-driven validation methods.
• Prior experience in startups or dynamic multidisciplinary environments.