agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.

Main tasks :

• Lead development and qualification of secondary and tertiary packaging solutions for combination products (pen and auto-injectors).
• Author and maintain GMP-compliant documentation including test plans, risk assessments, FMEAs, and control strategies.
• Conduct packaging testing (ASTM transport, aging, container closure integrity).
• Collaborate with cross-functional teams in Engineering, Quality, Regulatory, Manufacturing, and Human Factors.
• Ensure compliance with design control, medical device regulations, and quality standards.
• Manage supplier and CMO interactions including qualification and follow-up.
• Prepare business cases and support budget tracking.
• Drive project timelines and monitor deliverables.

Your profile :

• Master’s degree in Packaging, Device Engineering, Materials Science, or a related field.
• 3 to 8 years of experience in pharmaceutical or medical device packaging within GMP-regulated environments.
• Proven expertise in packaging qualification, project management, and technical documentation.
• Knowledge of ISO 9001, ISO 13485, ASTM D4169/D7386 standards.
• Familiarity with packaging manufacturing processes and equipment.
• IT proficiency: GMP documentation systems, Google Suite, MS Office, Visio, and project planning tools.
• Fluent in English (written and spoken).
• Strong interpersonal, networking, and communication skills

Thank you for your interest in this opportunity, please note that only the selected candidates for a first exchange will be contacted.