8758 Associate Engineer
The Associate Engineer is responsible for the execution and management of R&D and cGMP verification activities providing objective evidence that our medical device/combination products perform according to specified design/user requirements and applicable standards/regulations.
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.
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.
Report all atypical or unexpected events that occur during GMP activities to Lab Supervisor and/or Lab Manager as needed.
Support Discrepancy Management impact-assessment and Laboratory Investigations to confirm OoS test results or critical data and assign root cause.
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.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.