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Process Validation Expert

Novartis
Targu Mures, Romania Posted Jul 7, 2026
HybridUSD 81,900 - 152,100 / year

About this role

About the Role 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. You will work with cross-functional teams across sites, including the NVS site in Huningue, to drive alignment and implement best practices in process validation. What You'll Do

  • 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, root causes, and implementing 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. What We're Looking For
  • University degree in a scientific or engineering field (e.g., pharmacy, biotechnology, chemical engineering, engineering, pharmaceutical technology) or related discipline.
  • Minimum two years of experience in pharmaceutical or biotechnology manufacturing, process support, process validation, or related technical operations activities.
  • Strong understanding of manufacturing processes and ability to quickly learn complex production technologies.
  • Knowledge of quality standards, validation principles, and regulatory requirements in GMP environments.
  • Experience with manufacturing execution systems (MES) and enterprise resource planning (ERP) systems.
  • Strong communication and collaboration skills, with the ability to influence stakeholders across functions and sites.
  • Fluent English; basic knowledge of French is a plus. Nice to Have
  • Prior experience in biotechnology manufacturing environments (upstream and/or downstream).
  • Experience in Process Validation activities (PQ, CPV, Validation Lifecycle Management, Cleaning Validation), risk assessments, protocol/report writing, statistical analysis (JMP, Minitab), and CAPAs. Compensation & Benefits
  • Expected Annual Base Salary Range: 81,900 to 152,100 RON (salary currency shown as USD for platform purposes).
  • In addition to base salary, eligibility for performance-based bonus based on certain parameters.
  • Flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
  • Insurance and retirement plans, wellbeing resources, global recognition programs.
  • Commitment to diversity and inclusive culture; total rewards subject to local legal requirements.

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