Process Expert / Manufacturing Science and Technology

Key Responsibilities: 

• Using structured RCA (Root Cause Analysis) methodologies such as impact assessment, Fish bone diagram, 5 whys, Timeline & process mapping for investigation of deviations

• Handling Investigations and Deviations related to Process (Upstream / Downstream), Product & Equipment

• Understanding of core manufacturing unit operations such as sampling, monitoring, and continuous process support

• Handling procedural requirements for HA audits

• Responsible for offering technical and scientific expertise to address process-specific matters, ensuring compliance with cGMPs, SOPs (Standard Operating Procedures), and relevant guidelines and functional standards (such as HSE (Health, Safety and Environment) and NOSSCE)

• Handling internal and health authority audits and inspections

• Ensuring overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Essential Requirements:

• Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Master´s degree is a plus

• Min 5 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility

• Minimum 2 years of experience with deviation management and investigation

• Knowledge of risk assessment and risk management programs

• Fluent English, German is a plus

Desirable Requirements:

• Good communication, presentation and interpersonal skills

• Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistica etc.)

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.