This position reports into the Process Engineering group under Final Product Technologies. The position will support global supply, new product introductions, partnerships/acquisitions and devices. This position utilizes physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes.
A strong knowledge of common materials utilized in pharmaceutical packaging is required. Key Material knowledge requirements of the structural components and chemical properties of glass, polymers, adhesives, inks, varnishes and paper is required. Understanding of packaging manufacturing equipment and processes and how materials interact with these is essential to the position.
This role requires entry level management, excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.
- Management of entry level engineers and contingent workers.
- Evaluation, recommendation and selection of new packaging materials for both large and small molecules product.
- Assessing complex problems relating to materials, recommending and implementing solutions
- Write test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.
- Write Technical Specifications
- Representing Final Product Technologies as required
- Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes
- Establish priorities to ensure all projects are managed within expected due dates Lead and present new packaging ideas, concepts and design ideas to the Product Development team.
- Ensures cGMP and regulatory compliance are met
- Ensures that change control procedures are followed working with QA and Regulatory to implement changes
- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed
- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.
- MS in Materials Science, Mechanical Engineering, Chemical Engineering or packaging Engineering
- 3 or more years of packaging materials experience within the Pharma/Bio industry
- Leading teams
- Independent thinker with demonstrated skills working in teams or leading project teams
- Strong Interpersonal and communication skills
Ulrike De Smedt
+32 15 858 034