Packaging & Technology Engineer - Clinical Supply Chain

Pauwels Consulting; Beerse; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a qualified packaging and MSAT professional to coordinate the technical setup of clinical kit designs, including labeling and packaging processes for global studies.

You will manage packaging configurations, work with external partners, and oversee new compounds and equipment introductions for trials. Expectations include proficiency in validation/qualification and SAP/Trackwise for CAPA, in a multilingual, global setting.

Qualifications

• Bachelor or Master degree in a scientific or engineering discipline.
• Several years of relevant experience in packaging designs, materials, and production processes within life sciences.
• Technical knowledge of production equipment and experience with validation and qualification.
• Proficiency in SAP and Trackwise for CAPA and quality event management.
• You are experienced in project management and comfortable in a global, multi-compound environment.
• You are fluent in English and Dutch.

Responsabilités

• Coordinate the technical setup of clinical kit designs, including label requirements and packaging processes.
• Manage packaging configurations and technical requirements with internal teams and external partners.
• Oversee introduction of new compounds and equipment/materials for clinical trials.
• Support change management and manage non-conformance documentation including incident investigations.
• Participate in equipment validation and qualification activities for new study demands.
• Lead Process Excellence initiatives to optimize packaging quality, compliance, and timelines.

Connaissances

Packaging design

Materials handling

Production processes

Validation

Qualification

Project management

Multi-compound env

English/Dutch

Formation

Bachelor or Master degree in a scientific or engineering discipline

Outils

SAP

Trackwise

MS Project

Acrobat

Description du poste

Our client, a leading pharmaceutical organization, is seeking a professional to join their Manufacturing Science & Technology team. This role is responsible for the technical setup of kit designs and the end-to-end coordination of packaging and labeling requirements for global clinical studies.

• Coordinate the technical setup of clinical kit designs, including label requirements and packaging processes.
• Manage packaging configurations and technical requirements internally and with external partners for successful implementation.
• Oversee the introduction of new compounds and the implementation of new equipment or materials for clinical trials.
• Support change management processes and manage non-conformance documentation including incident investigations.
• Participate in equipment validation and qualification activities required for new study demands.
• Lead initiatives based on Process Excellence methodologies to optimize packaging quality, compliance, and delivery timelines.

• Bachelor or Master degree in a scientific or engineering discipline.
• You bring several years of relevant experience in packaging designs, materials, and production processes within the life sciences sector.
• You possess technical knowledge of production equipment and experience with validation and qualification.
• You have proficiency in SAP and Trackwise for CAPA and quality event management.
• You're experienced in project management and feel comfortable working in a global, multi-compound environment.
• You are fluent in English and Dutch.

Nice to Haves

• Experience with advanced therapies such as cell and gene therapy.
• Knowledge of MS Project and Acrobat.