Packaging Development Specialist

BioTalent; Eindhoven; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a highly experienced Primary Packaging Materials Scientist as a senior Subject Matter Expert (SME) to support primary packaging activities for parenteral pharmaceutical products. The candidate should have extensive experience with container closure systems, validation, and lifecycle management in a GMP environment. Responsibilities include leadership in technical design, executing validation studies, and supplier evaluation. This is an essential role to ensure compliance and quality in pharmaceutical manufacturing.

Qualifications

• Extensive experience with primary packaging materials for parenteral pharmaceutical products.
• Strong working knowledge of global pharmacopeial requirements.
• Significant experience operating within a GMP-regulated pharmaceutical environment.

Responsibilities

• Lead the design and development of Container Closure Systems for parenteral drug products.
• Plan and execute validation studies related to CCI and material verification.
• Evaluate and qualify new suppliers for packaging materials.

Skills

Technical Leadership

Container Closure Integrity (CCI)

Material qualification

Problem-solving

Education

MSc or PhD in a relevant Science or Engineering discipline

Job description

We are seeking a highly experienced Primary Packaging Materials Scientist to act as a senior Subject Matter Expert (SME) supporting primary packaging activities for parenteral pharmaceutical products.

This is a specialist-level position requiring deep technical expertise in container closure systems (CCS), regulatory documentation, validation, and lifecycle management within a GMP-regulated pharmaceutical manufacturing environment.

Key Responsibilities

Technical Leadership

• Lead the design and development of Container Closure Systems (CCS) for parenteral drug products
• Plan and execute validation studies, including:
• Container Closure Integrity (CCI)
• Material qualification and verification
• Provide technical oversight for lifecycle management of commercial primary packaging materials
• Evaluate, qualify, and implement new suppliers
• Lead investigations and troubleshooting for packaging-related manufacturing and quality issues
• Develop and defend technical strategies to internal and external stakeholders

Key Requirements

• MSc or PhD in a relevant Science or Engineering discipline (or equivalent experience)
• Extensive experience with primary packaging materials for parenteral pharmaceutical products
• Strong working knowledge of global pharmacopeial requirements (USP, Ph. Eur., JP, Chinese Pharmacopeia)
• Container Closure Integrity (CCI)
• Validation and verification of primary packaging materials
• Demonstrated experience authoring regulatory dossier sections
• Significant experience operating within a GMP-regulated pharmaceutical environment