Our expertise is not limited only to pharmaceutical and medical devices: our key scientific solution
is talented people who work together and
develop ideas that help other companies help people. In return, employees manage their careers
on their own. Because their ideas, large and small, improve the world. And that's the kind of work
we want to be part of.
We are currently looking a Packaging Engineer in the area of medical devices and pharmaceutical industry. Within this role you would ensure that project teams across the client applies world class standards and practices. In particular you would deploy and execute robust labeling approaches.
We currently have an opportunity for a Packaging Engineer to provide technical support for development of packaging, device and infusion technologies for combination products.
- Participate in new product development, particularly for combination products (Pre-filled syringes, pre-mix bags, pen injector, and/or Autoinjectors), injectable products, or other advanced delivery technologies.
- Establish internal lab testing capability and insure data integrity according to Standard Operation Procedures.
- Develop lab test fixtures, test methods, and perform Test Method Validation activities.
- Draft test protocols and reports following Good Documentation Practice.
- Utilize statistical analysis tool for design verification tests and Gage R&R studies.
- Work with project managers to insure completion of combination device deliverables within schedule.
- Work closely with cross functional team members, such as Formulation, Analytical, Quality Engineering, and Regulatory to assure all packaging or delivery devices meet the regulatory body requirements per the applicable region(s).
- Translate User Needs into Design Requirements, Perform DFMEA, and draft engineering product specifications.
- Possesses a Masters Degree or equivalent in packaging development or Engineering / Biomedical Engineering
- having minimum 10 years of experience in leading Consumer Packaged goods, medical devices, food or pharma Industry.
- Ability to learn FDA Design Control, from User Needs, Requirements Development, Risk Analysis, to Verification and Validation testing
- Exposure to different packaging technologies, packaging work processes, packaging suppliers and awareness of latest advances in the field of packaging.
- Healthcare industry experience is required with preferred emphasis in regulated consumer goods sector; Over the counter drugs or pharmaceutical products.
- Experience designing and implementing technical solutions to business problems is preferred.