Secondment via YER
Food, Feed, Pharma
Over deze vacature
For Amgen in Breda, YER is recruiting a Process Engineer. This position reports into the Process Engineering group under Final Product Technologies in Amgen. 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 are essential to the position.
Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.
Doing the right thing is central to our mission to serve patients. At Amgen, doing the right thing means more than just following their compliance policies. It also means truly living the Amgen values – being ethical, trusting and respecting each other, ensuring quality and being science-based.
Amgen foster a culture of diversity, inclusion and belonging. Their Diversity is a representation of everything that makes the staff unique, including gender, ethnicity, age, religion and thought. Their Inclusion is involving and empowering the staff and belonging is valuing the inherent worth and dignity of staff, so they feel authentic, safe and invited to thrive at work.
You will be employed by YER and seconded to Amgen. We offer:
- Good employee benefits;
- Excellent guidance from your consultant and YER's back office;
- Friendly atmosphere and open culture;
- Community/network with other technology professionals from a variety of multinationals;
- Events and master classes with interesting speakers and attractive companies.
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 a rapidly changing environment.
This specialist is responsible and accountable for the following:
- Evaluation, recommendation and selection of new packaging materials for both large and small molecules' product.
- Supports complex investigations relating to materials, recommending and implementing solutions
- Write test protocols, perform technical evaluations and submitting technical assessment reports justifying 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
- Write tech transfer plans and reports
- 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.
- Doctorate degree OR
- Master’s degree & 3 years of directly related experience OR
- Bachelor’s degree & 5 years of directly related experience
- MS in Materials Science, Mechanical Engineering, Chemical Engineering or packaging Engineering
- 7 or more years of packaging materials experience with 4+ years within the Pharma/Bio industry
- Leading teams
- Independent thinker with demonstrated skills working in teams or leading project teams
- Strong Interpersonal and communication skills