Reagent Manufacturing Engineer (Junior-level)

Title: Junior Reagent Manufacturing Engineer

Location: Redwood City, CA onsite.

Length of Contract: 6-12 months Contract with potential to contract-to-hire.

Hours:

Process: 1^st RD will be screened by Daniel, 30 minutes 1^st round. Virtual or Onsite interview 90 minutes.

Ideal Start date: The sooner we can find someone; they can get started on some of this project.

MSA in place: yes

Background Check Required

Position Summary:

This individual will work on Reagent Manufacturing engineering projects in the product development life cycle. The main areas of focus will be in New Product Introduction, Technology Transfer, and Sustain and Support activities. This individual will be responsible on working on projects of easy to moderate complexity depending on engineering needs.

Essential Duties and Responsibilities:

• Perform root cause analysis to identify reagent manufacturing failures and report results.
• Participate in labeling activities such as label creation, label specifications, and label troubleshooting.
• Participate in NCR and CAPA activities such as investigation and corrective action.
• Participate in developing, executing, and testing manufacturing related software such as the transition to electronic batch records in Reagent Manufacturing.
• Assist in writing and executing protocol for development, qualification, or validation of manufacturing processes. Additionally, writing reports for development, qualification, or validation of manufacturing processes.
• Develop, refine, and release SOPs, Forms, and Equipment documents (ex: IQ, OQ, PQ).
• Assist in optimizing the production processes by designing proof of concept fixtures, acquiring off-the-shelf tooling, and acquiring equipment for the production line.
• Assist in the process and equipment transfer from R&D into Reagent Manufacturing Operations.
• Participate in onboarding and negotiating with vendors and propose new technologies to support manufacturing automation advancement.
• Apply Six Sigma DMAIC and LEAN methodology to reduce process variability and improve cost savings in Reagent Manufacturing.
• Develop process documentation and implementing process improvements that increase yield, efficiency, and throughput.

Qualifications:

• Requirements:
  • A Batchelor of Science degree in engineering or science, preferably in molecular biology, biochemistry, bioengineering, mechanical engineering or a closely related discipline. A Master of Science of a similar discipline will also be considered.
  • 0-3 years of experience in a relevant field.
  • Experience with engineering fundamentals
  • Experience with critical thinking and problem solving.
  • Experience in data analysis and troubleshooting technical problems.
  • Experience in executing engineering or science projects to completion/launch.
  • Proficient in working with Google Suite and Microsoft360 products.
  • Strong communication and collaborative skills.

• Nice to have:
  • Experience working within regulated environments (FDA, IVD, LDT, ISO, etc.)
  • Experience with liquid handling robotic platforms (Hamiltons, Bravos, etc.)
  • Experience with automated development of next-generation sequencing (NGS) assays
  • Experience with standard molecular biology techniques such as nucleic acid isolation and purification, DNA quantitation, PCR, etc.
  • Experience with software programing (JavaScript, Python, etc.)