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Senior Packaging Engineer

vor 2 Monaten


Basel, Basel-Stadt, Schweiz Sobi group Vollzeit
Job Summary

We are seeking a highly skilled Senior Packaging Engineer to join our team at Sobi Group. As a key member of our packaging development team, you will be responsible for ensuring the quality and compliance of secondary packaging development for medical devices and combination products worldwide.

Key Responsibilities
  • Lead packaging development activities for drug product and combination product projects, including development projects for new products and remediation activities for commercial products.
  • Align with Regulatory Affairs on the space requirements for labelling information in all relevant markets.
  • Work with suppliers and Contract Manufacturing Organizations (CMOs) on materials and packaging processes.
  • Gather input from Human Factors Engineering and Risk Management to address respective needs.
  • Lead shipping verification studies or write the respective shipping Verification Risk Assessment.
  • Optimize packaging on sustainability aspects to minimize use of material and space to reduce carbon footprint.
Requirements
  • Minimum Bachelor of Science in a technical field, ideally chemical engineering or comparable.
  • Minimum 5 years work experience in a pharmaceutical/medical device company.
  • Hands-on experience in testing in laboratories and manufacturing sites.
  • Demonstrated practical use of GMP relevant regulatory Guidelines.
  • Experience of GMP Production and typical filling, packaging & labelling machines.
  • Knowledge of MDR, ISO 11607, ASTM 4169, EMEA, FDA and other regulatory requirements.
Preferred Qualifications
  • Experience with electronic document management systems and tools.
Personal Attributes
  • Attention to detail and accuracy.
  • Ability to work independently and as part of a team.
About Sobi Group

Sobi Group is a global company with over 1,700 employees in more than 30 countries. We are committed to the societies where we operate and are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease.

We believe that our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

We are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. All employment decisions at Sobi Group are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans, and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.