Product Testing and Design Verification:
- Execute GMP Testing Protocols (Design Verification, Test Method Validation, and Complaints Investigations) using knowledge of Design Requirements, Validated Test Methods, and analytical instruments.
- Record GMP Data in Laboratory Notebook and Document Control systems.
- Review GMP data for technical accuracy, completeness, and cGDP compliance.
- Execute R&D / characterization testing or special Test Requests as needed to support the development and selection of device designs, components, test methods or operating procedures.
- Collection of mechanical testing data to aid in the characterization, selection, Design Verification, and commercialization of drug delivery devices.
- Laboratory Management
- Assist Lab Manager and Lab Supervisor in all aspects of maintenance and operation of the Device Development laboratory.
- Collaborate with the Equipment Qualification Team and Instrument Services to maintain lab infrastructure of qualified instruments, validated methods, and computer systems.
- Maintain cleanliness, safety, and usability of laboratories and storage spaces.
- Communicate to lab users and internal stakeholders regarding new procedures, requirements, and potential non-compliance.
- Collaboration with Device Engineers, Process Engineers, and the Laboratory Supervisor to identify, develop, implement, qualify and validate new test methods, procedures, and processes.
- Materials Management (GMP and R&D)
- Execute GMP Environmental Monitoring activities including, but not limited to: alarm checks, equipment inspections, supplemental temperature monitoring, and associated documentation for all sample storage/conditioning CTEs and Cold/Warm Rooms under Device Development Management.
- Manage and maintain GMP Test Sample Inventory documentation and chain-of-custody audit trail per appropriate cGDP standards and requirements.
- Record, coordinate, and oversee sample transfers between storage facilities to maintain accurate chain-of-custody audit trails.
Regulatory Compliance / General:
- Conduct ongoing compliance and safety assurance activities as assigned by the Lab Supervisor.
- Ensure cGDP and cGLP compliance for data, equipment, test samples, chemicals, materials, etc.
Maintain up-to-date training status on appropriate standards, procedures, methods, and work instructions
Education and Experience
- AA/AS in a technical or life sciences field required (mechanical, biological, biomedical, chemical engineering/technology) or equivalent 2-5 yrs of experience in the Pharmaceutical, Biotech, or Medical Device industry or an equivalently-regulated environment (e.g. ISO compliant).
- B.S. degree in an engineering field (mechanical, biological, biomedical, chemical) or equivalent and 0-2 years experience.
- Experience in R&D and GMP environments is desired, and an understanding of the differences between these environments is critical.
- Direct experience in executing physical/functional Test Methods and following SOPs / Protocols is highly desired.
- Familiarity with tensile/torque testing systems is highly desired (Instron, Zwick, Mecmesin).
- Familiarity with analytical instruments is highly desired (Balances, etc.)
- Familiarity with dimensional analysis/metrology equipment is highly desired (Microscopes, Gages, Calipers, Vertex).
- Familiarity with Operational Excellence Initiatives, Lean Six Sigma, 5S, Kaizen, and/or Value Stream Mapping is a plus.
- Must be highly organized, analytical, detail oriented and able to conduct work independently.
- Able to conduct work on multiple projects with precision.
- Team oriented, creative, eager to take on responsibility.
- Excellent written and verbal communication skills are required.
- Demonstrated ability to communicate with internal stakeholders and external collaborators.