12862 - Validation Lead

Qualitest, the World’s Leading AI-Powered Quality Engineering Company

At Qualitest we're all about ensuring everything runs smoothly, whether it's your business, technology, or operations. We leverage smart engineering-led practices and precise processes to maintain excellence in all that we do.

Our clients are the world’s top brands and our diverse global team of 8,000 employees, including 1,500 in Israel, collaborates with industry leaders in technology, finance, insurance, and beyond, making a significant impact in the world of technology.

We offer creative and flexible solutions to ensure the quality of your business operations, safeguarding your brand's reputation. We're proud to say we've been pushing the boundaries for over 25 years now, always striving for innovation and delivering exceptional service.

Ready to make a difference? Join our dynamic and forward-thinking team!

Qualitest is growing and we are looking for a Validation Lead 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.

Requirements

• BA/BSc degree or equivalent in Science or Engineering is required, or a technical diploma with practical engineering experience.
• 3-5 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.

Why should you join us?

• Recognized among Israel's top 100 best places to work for, four years in a row
• Be part of a company that is a globally recognized leader in Quality Engineering
• Experience our team spirit, working with real people, and solving real challenges
• Work with Senior Specialists and Practice Experts. · Nurture your personal and professional growth through tailored career paths
• Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers
• Enjoy unique placement opportunities worldwide
• We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential