Process Validation Expert

About the role

Novartis is seeking a Process Validation Expert to ensure that life‑changing medicines are produced reliably, safely and efficiently. Based in Targu Mures, Romania, you will work closely with manufacturing, quality and technical operations teams as well as the Novartis site in Huningue to drive cross‑site alignment and best‑practice implementation.

Key responsibilities

• Serve as Subject Matter Expert for assigned products and manufacturing processes, providing technical support to maintain continuity.
• Lead and support the full validation lifecycle, including Process Qualification, Continued Process Verification, and validation strategy development.
• Partner with cross‑functional teams and the Huningue site to share knowledge and align validation activities.
• Investigate process deviations, identify root causes and implement corrective and preventive actions.
• Manage process changes through formal change control, ensuring regulatory compliance.
• Support internal and external inspections and evaluate process performance trends for continuous improvement.

Required profile

• University degree in pharmacy, biotechnology, chemical engineering, pharmaceutical technology or a related scientific/engineering discipline.
• Strong understanding of GMP‑regulated manufacturing processes and the ability to learn complex production technologies quickly.
• Fluency in English; basic knowledge of French is desired.
• Experience in pharmaceutical or biotechnology manufacturing, process support or validation is preferred.

Required skills

• Good Manufacturing Practices (GMP) knowledge.
• Process Validation techniques: Process Qualification (PQ), Continued Process Verification (CPV), Cleaning Validation.
• Risk assessment, change control, CAPA management.
• Statistical analysis tools such as JMP or Minitab.
• Experience with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems.

What we offer

• Annual base salary between RON 81,900 and RON 152,100, plus performance‑based bonus potential.
• Competitive benefits including insurance, retirement plans, wellbeing resources and flexible hybrid working options.
• Minimum 14 weeks paid parental leave and a commitment to pay equity and diversity.