Pharmaceutical Product Engineer
Responsibilities of the Pharmaceutical Product Engineer:
- Develop project plans and corresponding project management tools to support the execution of all projects.
- Manage project activities and provide technical leadership and support to external partners.
- Execute Human Factors Engineering and Usability activities.
- Write protocols, reports, specifications, procedures, change control requests, technical assessments to progress development of a pre-filled syringe.
- Develop and perform tech transfer and development of a pre-filled syringe.
- Ensure efficient transfer of products and on-going product support to CMOs to enable development of a pre-filled syringe.
- Assure adherence to latest global regulatory rules and guidance concerning devices and combination products and develop device risk mitigations.
- Create, maintain and update device related documents required for regulatory filings and compliance.
- Contributes to authoring CMC sections of regulatory submission documents.
Requirements of the Pharmaceutical Product Engineer:
- BS, MS, or PhD in a related Engineering discipline (Mechanical, Electrical, Chemical, Biomedical, or Biochemical engineering).
- Must have 8+ years of experience in Pharmaceuticals, Medical Devices, or Biotechnology.
- In-depth understanding of device development and verification activities including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to devices.
- Must have experience with In-depth knowledge of parenteral delivery devices (e.g., pre-filled syringes, self/ or auto-injectors), etc.
- Paid time off
- Medical and dental insurance
- 401K Match
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.