Process Validation Expert

About the role

Novartis is looking for a Process Validation Expert (internal title: Process Expert) based in Targu Mures, Romania, working in a hybrid setting. The role provides technical and scientific expertise to support process validation across the product lifecycle, keeping manufacturing processes robust, compliant and inspection-ready. It works closely with manufacturing, quality and technical operations teams and with the Novartis site in Huningue.

Key responsibilities

• Serve as Subject Matter Expert for assigned products, processes and 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 knowledge sharing.
• Support investigations of process deviations, identify root causes and implement corrective and preventive actions.
• Oversee process changes through formal change control, ensuring regulatory compliance.
• Lead and support process validation lifecycle activities, including process qualification, continued process verification and validation strategy development.
• Support internal and external inspections and ensure readiness and adherence to regulatory expectations.
• Evaluate process performance trends and drive continuous improvement and product quality enhancements.

Required profile

• 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 ability to quickly learn complex production technologies.
• Knowledge of quality standards, validation principles and regulatory requirements in a GMP environment.
• Experience with manufacturing execution systems and ERP systems.
• Fluent English; basic French is desired.
• Desired: experience in pharmaceutical or biotechnology manufacturing, process support or validation.

Required skills

• Good Manufacturing Practices (GMP)
• Process and cleaning validation, including process qualification (PQ) and continued process verification (CPV)
• Change control, risk assessment, protocol and report writing, statistical analysis (e.g. JMP, Minitab)
• Support of deviations, investigations, change controls and CAPAs

What we offer

• Base salary range of RON 81,900 to RON 152,100, set according to skills, competencies and experience.
• Possible performance-based bonus.
• Competitive benefits in kind such as insurance and retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options where possible, and at least 14 weeks of paid parental leave.