Production Support Engineer II

We're seeking an experienced Production Support Engineer to join our high complexity laboratory team.  This is a vital role within our lab that is responsible for providing first tier support to the laboratory production lines.  

 San Francisco, CA onsite

Sunday-Thursday 7:00am - 3:30pm

• Provide first tier support for instruments not operating to specifications/requirements and resolve all hardware and software errors on our highly-automated laboratory production lines in a timely manner and to quality standards with minimal supervision or independently depending on experience utilizing SOPs, training, and engineering (optical, mechanical, electrical, or fluidics) fundamentals.
• The scope of support includes installation, calibration, maintenance, and repair of both simple (i.e. plate sealers) and complex (i.e. liquid handling robotics) instrumentation with all work and activities documented in the company’s Quality Management System (QMS), ticketing systems, and confluence pages using GDocP and detailed technical writing that complies to both regulatory and quality requirements, policies, and procedures.
• Communicate and document status of production lines and support efforts to Shift Supervisor, Team Lead, and Production Lab staff each shift. Identify blockers and specify next steps, including whether technical support is required from automation teams or vendors. Escalate critical issues in a timely manner to team Supervisors and Manager.
• Partner with different departments to develop or improve qualification (IQ/OQ/PQ/PPQ), calibration, corrective maintenance (CM), preventive maintenance (PM) and predictive (PdM) maintenance requirements for instruments as needed to comply with design requirements, operational needs, regulations and applicable standards.
• Drive Corrective Action and Preventive Action (CAPA) efforts, perform root cause analysis (RCA) of diverse problems, and compile/analyze data to understand component level failures of instrumentation with the goal to drive solutions to improve equipment reliability and uptime.
• Identify trends and areas for improvement in support activities. Review team metrics and instrument performance metrics. Make suggestions for continuous improvement, cost savings, and implement changes to ensure ongoing high-quality performance of clinical laboratory equipment.
• Complete training and competency assessments in the required timeframe; Train new team members and ensure their competency. May coach and mentor junior or new team members, offering guidance to team members who are developing skills.
• Other duties as assigned by their supervisor.

• Bachelor’s Degree in an engineering or scientific discipline, or comparable industry experience in Life Sciences, Pharmaceutical, or Medical Devices industries.
• 2 years minimum of related or equivalent work experience.
• Fundamental comprehension of optical, mechanical, electrical, and/or fluidic systems.
• Experience working in a high sample volume FDA, ISO 13485/15189, GMP, GLP and/or CAP/CLIA environment strongly preferred.
• Familiarity with Next Generation Sequencing (NGS) technology strongly highly desirable.
• Strong working knowledge in the areas of laboratory technology, laboratory information management systems (LIMS), and automated workflows/processes a plus.