Primary Packaging Change Lead

BioTalent; Brussel; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

BioTalent seeks a hands-on Primary Packaging Engineer to manage supplier-initiated changes for packaging components such as vials, syringes, blisters, bottles, bags and cassettes. The contractor will assess impact on internal and external manufacturing partners and ensure alignment with quality, regulatory and product requirements.

The role requires 3–8 years of experience in supplier change management or related areas, with strong execution discipline and the ability to collaborate across

Qualifications

• Experience in primary packaging, supplier change management, quality, regulatory affairs, QC, materials science or pharmaceutical manufacturing support.
• Strong attention to detail and ability to manage multiple change requests in a structured way.

Responsabilités

• Manage supplier-initiated changes for primary packaging components from receipt through assessment and closure.
• Assess the potential impact of supplier changes on drug product, and where relevant, drug substance.
• Evaluate implications for regulatory requirements, quality, QC and affected products or stakeholders.
• Coordinate with cross-functional stakeholders to ensure impact assessments are completed accurately and on time.
• Review and apply relevant supplier agreements and existing change-management processes.
• Support continuous improvement by identifying opportunities to simplify and optimise the change-management process.

Connaissances

Primary packaging

Supplier change management

Quality

Regulatory affairs

Materials science

Formation

Engineering degree

Pharmacy degree

Materials science degree

Description du poste

BioTalent seeks a hands-on Primary Packaging Engineer to manage supplier-initiated changes for packaging components such as vials, syringes, blisters, bottles, bags and cassettes. The contractor will assess impact on internal and external manufacturing partners and ensure alignment with quality, regulatory and product requirements.

The role requires 3–8 years of experience in supplier change management or related areas, with strong execution discipline and the ability to collaborate across