Medical Device Verification Technician
500 Forbes Boulevard South San Francisco, CA 94080
Bayside Solutions is seeking a Medical Device Verification Technician to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Medical Device Verification Technician:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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 the 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 & Safety Assurance:
- 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.
Summary of Qualifications:
- AA/AS in a technical or life sciences field required (mechanical, biological, biomedical, chemical engineering/technology) or equivalent. Higher level education a plus.
- 2-4 yrs of experience in the Pharmaceutical, Biotech, or Medical Device industry or an equivalently-regulated environment (e.g. ISO compliant).
- 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 dimensional analysis/metrology equipment is highly desired (Microscopes, Gages, Calipers, Vertex).
- Experience in R&D and GMP environments is desired, and an understanding of the differences between these environments is critical.
- Familiarity with design principles, design control, URs/DIRs, 3D modeling software (CAD) and rapid prototyping instrumentation is a plus.
- 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.