MSAT Investigation Associate

Pauwels Consulting; Sint-Denijs-Westrem; Sur place; EUR 90 000 - 110 000; Plein temps

Résumé du poste

Pauwels Consulting is partnering with a leading biotechnology company to hire a seasoned professional to lead manufacturing investigations in a GMP cell and gene therapy environment.

You will drive root cause analysis, oversee CAPA and process improvements, and support regulatory inspections while drafting critical technical documentation for change controls and qualification protocols.

Qualifications

• 8+ years of experience in process engineering or manufacturing science within a GMP environment.
• Experience leading manufacturing investigations including root cause analysis and CAPA.
• In-depth knowledge of cell and gene therapy processes and technologies.
• Experience with regulatory compliance and defending investigation strategies during inspections.
• Strong communication skills to coordinate with cross-functional stakeholders.

Responsabilités

• Lead complex manufacturing investigations and establish strategies for root cause analysis to support critical product release windows.
• Oversee the implementation of CAPAs and process improvements in collaboration with technical process experts and engineers.
• Act as the primary support for regulatory authority inspections regarding manufacturing science and technology subjects.
• Draft and review technical documentation including impact assessments, change controls, and qualification protocols.
• Provide technical expertise to troubleshoot scientific and manufacturing issues on the shopfloor.
• Perform data trending and analysis to identify opportunities for continuous process improvement and robustness.

Connaissances

Process engineering

Manufacturing science

Root cause analysis

CAPA implementation

GMP experience

Cell and gene therapy

Regulatory collaboration

Cross-functional communication

English proficiency

Description du poste

Our client, a leading biotechnology company specializing in advanced therapies, is seeking a professional to lead manufacturing investigations. The role focus on driving root cause analysis and ensuring process robustness within a cell and gene therapy environment.

• Lead complex manufacturing investigations and establish strategies for root cause analysis to support critical product release windows.
• Oversee the implementation of CAPAs and process improvements in collaboration with technical process experts and engineers.
• Act as the primary support for regulatory authority inspections regarding manufacturing science and technology subjects.
• Draft and review technical documentation including impact assessments, change controls, and qualification protocols.
• Provide technical expertise to troubleshoot scientific and manufacturing issues on the shopfloor.
• Perform data trending and analysis to identify opportunities for continuous process improvement and robustness.

• You have 8+ years of relevant experience in process engineering or manufacturing science within a GMP environment.
• You bring expertise in leading manufacturing investigations including root cause analysis and CAPA implementation.
• You possess in-depth knowledge of cell and gene therapy processes and process technologies.
• You have experience with regulatory compliance and defending investigation strategies during inspections.
• You're a strong communicator capable of coordinating with cross-functional stakeholders in a matrixed environment.
• You are fluent in English.

Nice to Haves

• Knowledge of Dutch.
• Willingness to work in shifts and on weekends.