#12862 - Validation Expert

Qualitest is the world's leading AI-Powered Quality Engineering Company.

We bring in the culture of quality orchestration, technology and operational landscape through our engineering-led, process discipline.

We provide innovative and scalable business quality engineering solutions that protect our clients' brand through end-to-end value demonstration with laser focus on customer experience and release velocity. This year we are celebrating 25 years of innovation and excellence.

Every day with Qualitest is an opportunity to innovate, grow and change.

We've assembled one of the largest, most talented groups of creative, critical problem-solvers in the world with over 7000 engineers.

Talented, intelligent, and passionate people have made Qualitest the world's leading Quality Engineering company. If you want to learn from the best, there's no better place to start!

Qualitest is growing and we are looking for a Validation Expert to join our team in Netanya

Responsibilities{{:}}

• Develop and execute validation protocols for equipment, processes, systems, and facilities used in pharmaceutical manufacturing, ensuring compliance with regulatory requirements such as FDA, EMA, and ICH guidelines.
• Design and implement validation strategies for new product introductions, process improvements, and technology transfers.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs, to ensure alignment on validation activities and timelines.
• Review and approve validation documentation, including protocols, reports, deviations, and change controls, to ensure accuracy, completeness, and compliance with regulatory requirements.
• Conduct validation studies, including equipment qualification, process validation, cleaning validation, and computer system validation, according to approved protocols and schedules.
• Investigate and resolve deviations, non-conformances, and out-of-specification results related to validation activities, implementing corrective and preventive actions as needed.
  
  

• BA/BSc degree or equivalent in Science or Engineering is required, or a technical diploma with practical engineering experience.
• 5-10 years' experience in the pharma industry
• Required knowledge and experience with equipment & utilities validation, preferred knowledge and experience with water systems, validations.
• Knowledge and experience with generating, revises and executes documentation for validation studies ensuring compliance with QA and cGMP systems.
• Performing DQs, Impact Assessments, Criticality Assessments.
• Knowledge and experience with generating and executing validation protocols Writing IQ, OQ and PQ protocols, executing validations per protocols, Writing IQ, OQ and PQ Reports. Performing and summarizing various annual testing.
• Knowledge and experience with discrepancies, deviations and RC investigations writing required.
• Knowledge of GMPs related to validations for biologics and combination products is preferred.
  
  

• Be a part of a leading Engineering company, globally recognized as a Visionary by Gartner Magic Quadrant
• Have continuous access to and work with Senior Quality Engineers and Experts
• Work with cutting-edge technology in a company built by Quality Engineers for Quality Engineers. This is what we do!
• Access to Learning & Development opportunities for building a strong and lasting career
• A supportive and inclusive work environment with truly good people
• As a global company, we offer unique placement opportunities around the world
• Our Qualitesters are the reason for our success. We constantly encourage career development and promote from within
  
  

• Visit our website at https{{:}}//qualitestgroup.com/
• Check out our Career page{{:}} https{{:}}//qualitestgroup.com/careers/open-positions/