- 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.
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Production Support Engineer - San Francisco, United States - Invitae
Description
Invitae is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae's genetics experts apply a rigorous approach to data and research, serving as the foundation of their mission to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people.
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.
Location: San Francisco, CA onsite
Schedule: Sunday-Thursday 7:00am - 3:30pm
What you'll do:
California Pay Range
$76,500-$95,600 USD
Please apply even if you don't meet all of the "What you bring" requirements noted. It's rare that someone checks every single item, it's ok, we encourage you to apply anyways.
Join us
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
We truly believe a diverse workplace is crucial to our company's success and to better serve our diverse patients. Your input is especially valuable. We'd greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous.
You can find a detailed explanation of our privacy practices here.