Validation & Documentation Specialist

Validation & Documentation Specialist

Ravona LTD • Full-time • Modi’in-Maccabim-Reut, Center District, Israel • On-site

Ravona LTD is an Israeli engineering and manufacturing company specializing in advanced equipment for the pharmaceutical, biotechnology, medical, chemical, and cosmetics industries.

Our solutions include aseptic and containment isolators, sterility-testing isolators, RABS, VHP decontamination systems, glove-integrity testers, passboxes, and integrated fill-and-finish applications.

We are looking for a highly organized and detail-oriented Validation & Documentation Specialist to prepare, manage, and execute validation documentation for pharmaceutical equipment and systems.

The role involves close collaboration with R&D, engineering, automation, quality, production, project management, suppliers, and customers in Israel and internationally.

• Prepare and manage validation documentation throughout the equipment lifecycle.
• Develop and maintain validation documents, including:
• Validation Master Plans
• Design Qualification (DQ)
• Factory Acceptance Test (FAT) protocols
• Site Acceptance Test (SAT) protocols
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ), when applicable
• Requirements Traceability Matrices
• Risk assessments and deviation reports
• Technical documentation.
• Review customer User Requirement Specifications (URS) and translate them into validation and documentation requirements.
• Review technical specifications, functional descriptions, electrical drawings, P&IDs, component lists, and operating sequences.
• Prepare equipment manuals, operating instructions, maintenance procedures, calibration lists, and technical files.
• Participate in the execution of FAT, SAT, IQ, and OQ activities.
• Record test results and ensure that all documentation is accurate, complete, and properly approved.
• Manage deviations, open items, corrective actions, and validation reports.
• Ensure document control, revision control, traceability, and compliance with approved procedures.
• Support customers during document reviews, audits, inspections, and equipment qualification activities.
• Coordinate documentation requirements with internal departments, subcontractors, and external suppliers.
• Maintain validation schedules and ensure that documentation is completed in accordance with project milestones.

• Bachelor’s degree or practical engineering qualification in engineering, life sciences, biotechnology, chemistry, quality assurance, or a related field.
• Previous experience in validation, qualification, quality assurance, or technical documentation within the pharmaceutical, biotechnology, medical-device, or regulated-equipment industries.
• Familiarity with GMP principles and pharmaceutical validation requirements.
• Understanding of FAT, SAT, IQ, OQ, PQ, risk assessments, deviations, and traceability.
• Strong technical understanding and the ability to read engineering documents and specifications.
• Excellent written and spoken English — mandatory.
• Good written and spoken Hebrew.
• High proficiency in Microsoft Word and Excel.
• Excellent attention to detail, organization, and document-management skills.
• Ability to manage several projects and priorities simultaneously.
• Strong communication skills and the ability to work effectively with multidisciplinary teams.
• Willingness to participate in customer activities and travel when required.

• Experience with aseptic processing equipment, isolators, RABS, VHP systems, filling lines, or cleanroom equipment.
• Knowledge of EU GMP Annex 1, GAMP 5, FDA 21 CFR Part 11, data integrity, and ISO standards.
• Experience preparing validation documentation for automated systems, PLCs, HMIs, and computerized systems.
• Experience working directly with international pharmaceutical customers.
• Familiarity with SolidWorks drawings, electrical drawings, or P&IDs.
• Experience with document-management or quality-management systems.

• A key position in a growing international engineering and manufacturing company.
• Involvement in advanced pharmaceutical and aseptic-processing projects.
• Collaboration with engineering teams, global customers, and leading pharmaceutical manufacturers.
• Professional development in validation, automation, pharmaceutical equipment, and quality systems.
• A dynamic, multidisciplinary, and hands-on working environment.

Employment type: Full-time

Work location: On-site, Modi’in-Maccabim-Reut, Israel

Candidates are invited to submit their CV in English:

[email protected]

• The position is open to all qualified candidates, regardless of gender.