Process Expert BIOVE

Job Description Summary

Job Description

Key Responsibilities

• Provide expert front-line support to manufacturing teams across compounding filling and packaging operations

• Ensure safe timely and compliant batch production aligned with quality and standards

• Act as Subject Matter Expert (SME) for product and process knowledge within VE/BIO operations

• Evaluate and troubleshoot product and process-related issues as first-line support

• Maintain manufacturing processes at inspection readiness and regulatory compliance

• Own and update master manufacturing documents to reflect current standards and changes

• Lead deviation investigations root cause analysis and CAPA development and execution

• Manage complaint handling and support Health Authority inspections

• Identify and implement process improvements to enhance efficiency and quality

• Challenge existing manufacturing practices to drive continuous improvement and innovation

• Coordinate Operational excellence for the VE and BIO processes

Essential Requirements

• Degree in a scientific field such as Pharmaceutical Sciences Biomedical Sciences or Engineering

• Minimum 3 years of experience in GMP-regulated pharmaceutical operations

• Strong understanding of pharmaceutical processes regulatory standards and quality systems

• Fluent in Dutch with good proficiency in English

• Strong analytical thinking and problem-solving skills

• Excellent communication and stakeholder management abilities

Desirable Requirements

• Experience with validation deviation handling and CAPA implementation

• Knowledge of aseptic techniques and biotech manufacturing environments

What You Can Expect from Us

Youll join an open and stimulating company culture where collaboration growth and well being are at the heart of everything we do. We offer you the opportunity to develop yourself and expand your knowledge across various domains.

At our Puurs site we place great importance on both the physical and mental well-being of our employees. Thats why we provide a supportive work environment that includes: a bike leasing program an on-site fitness facility freely accessible to employees and the presence of a mental coach on site.

Commitment to Diversity and Inclusion

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

Skills Desired