Process Validation Expert

#LI-HybridLocation: Targu Mures, RomaniaInternal job title: Process ExpertRelocation Support: This role is based in Targu Mures, Romania. Novartis is unable to offer relocation support: please only apply if accessible.Play a key role in ensuring life-changing medicines are delivered to patients, reliably, safely, and efficiently. As a Process Validation Expert, you will provide technical and scientific expertise to support process validation activities across the product lifecycle, ensuring manufacturing processes remain robust, compliant, and inspection-ready. Working closely with manufacturing, quality, and technical operations teams, as well as our Novartis (NVS) site in Huningue, you will drive cross-site alignment, knowledge sharing, and the implementation of best practices in process validation. Your expertise will help maintain a reliable product supply while supporting continuous improvement, operational excellence, and regulatory compliance.

Key Responsibilities:Serve as Subject Matter Expert for assigned products, manufacturing processes, and process validation activities, ensuring reliable and compliant execution.Provide technical support to enable smooth process execution and maintain manufacturing continuity.Partner with cross-functional teams, including the NVS site in Huningue, to drive alignment and effective knowledge sharing.Support investigations of process deviations, identifying root causes and implementing appropriate corrective and preventive actions.Oversee process changes through formal change control, ensuring full regulatory compliance.Lead and support process validation lifecycle activities, including process qualification, continued process verification, and validation strategy development.Support internal and external inspections, ensuring strong readiness and adherence to regulatory expectations.Evaluate process performance trends and drive continuous improvement, innovation, and product quality enhancements.Essential Requirements:University degree in a scientific or engineering field such as pharmacy, biotechnology, chemical engineering, engineering, pharmaceutical technology, or a related discipline.Strong understanding of manufacturing processes and the ability to quickly learn complex production technologies.Knowledge of quality standards, validation principles, and regulatory requirements within a GMP-regulated environment.Experience working with manufacturing execution systems and enterprise resource planning systems.Strong communication and collaboration skills, with the ability to influence stakeholders across different functions and sites.Fluency in English is needed, basic knowledge of French language is desired.Experience in pharmaceutical or biotechnology manufacturing, process support, process validation, or related technical operations activities is desired.Desirable Requirements:Prior experience in biotechnology manufacturing environments, including upstream (USP) and/or downstream (DSP) processes.Experience in Process Validation activities, including Process Qualification (PQ), Continued Process Verification (CPV), Validation Lifecycle Management, Cleaning Validation, risk assessments, protocol/report writing, statistical analysis (e.g., JMP, Minitab), and support of deviations, investigations, change controls, and CAPAs.Benefits & Rewards: At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.   Expected Annual Base Salary Range for role:RON 81.900,00 to RON 152.100,00  The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.   In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.   The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.   Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.   Read our brochure to learn more about our global total rewards offering:   https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf   Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.  Commitment to Diversity and Inclusion / EEO paragraph: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.