Validation & Documentation Specialist

Company Description

Since 1965, Ravona LTD has specialized in producing high-quality Aseptic and Containment Isolators as well as Glove Integrity Testers for industries worldwide. Serving diverse sectors, Biopharma, Pharma, and chemicals, Ravona is dedicated to professionalism and client commitment. Our success is driven by meeting the evolving needs of customers and delivering high-quality, customized solutions. Leveraging advanced technologies, we lead in metal treatment, pneumatic and electric equipment, and electronic microprocessor-based controllers. Our experienced staff and state-of-the-art technology ensure top-notch service and customer satisfaction.

Role Overview

The Validation & Documentation Specialist is responsible for planning, executing, documenting, and maintaining all validation activities and technical documentation across engineering and pharmaceutical equipment projects. This includes supporting equipment lifecycle from URS and design stages, through FAT/SAT, to IQ/OQ/PQ execution, as well as authoring regulatory documents and supporting engineering, production, and quality teams.

This position is suited for a highly organized, detail-oriented individual with technical understanding and regulatory awareness.

Key Responsibilities

1. Validation Activities

• Preparation and execution of validation protocols: IQ, OQ, PQ.

• Supporting validation of equipment such as RABS/Isolators, Glove Integrity Testers, filling lines, tunnels, lyophilizers, FFUs, and related systems.

• Change Control documentation and tracking.

• Software validation (CSV) according to GAMP 5.

• Ensuring compliance with Data Integrity and 21 CFR Part 11.

• Handling deviations, non-conformances, and CAPA documentation.

2. Technical Documentation Management

• Writing and maintaining:

URS, FDS, SDS, HDS, Manuals, Risk Assessments, Traceability Matrices, SOPs.

• Preparing FAT/SAT documentation and supporting execution.

• Creating complete machine documentation packages for customers (manuals, drawings, certificates).

• Revision control, versioning, and configuration management.

3. Engineering Project Support

• Close cooperation with mechanical, control, electrical, and software engineers.

• Assisting with project technical files, regulatory dossiers, and customer documentation.

• Tracking action items, ensuring project milestones and deliverables are met.

• Communication with customers, suppliers, auditors, and regulatory bodies.

4. On-Site Testing & Qualification

• Participation in FAT at the manufacturing site and SAT at customer sites.

• Execution of IQ/OQ at customer facilities, including functional tests, safety tests, measurements, and calibrations.

• Real-time troubleshooting and coordination with engineering teams.

• Preparing and archiving complete validation reports.

5. Required Qualifications

• Proven experience in validation within the pharmaceutical / medical device / industrial automation field.

• Experience writing and executing IQ/OQ/PQ and FAT/SAT protocols.

• Technical understanding of mechanical systems, automation, PLC/HMI.

• Strong command of English (reading, writing, speaking).

• High-level organizational skills and attention to detail.

• Ability to work independently across multiple simultaneous tasks.

• Familiarity with relevant standards:

• GMP, GAMP 5, ISO 14644, Annex 1, 21 CFR Part 11.