Senior Manufacturing Engineer
Quantum-Si is seeking a talented and experienced Sr. Manufacturing Engineer – Reagents to join the Operations team specifically supporting the Reagents Manufacturing workstream. The scope of the role includes, but is not limited to the requirements definition, scoping, acquisition, commissioning, process development, and ultimate qualification of production processing equipment in addition to sustaining these processes in manufacturing (bioprocessing through fill/finish and packaging).
As part of our team, your core responsibilities will be:
· Support in all areas of reagent manufacturing engineering serving as a technical lead with guidance and alignment from the Director of Manufacturing Engineering and other leaders within Operations
· Own the manufacturing equipment in all aspects of its lifecycle from purchasing, development, commissioning, installation, training, process development, calibration, validation, sustaining, etc.
· Partner with the Manufacturing and Quality teams in the Reagent Factory program execution, concurrent investigations, system design and development, and more
· Perform and/or review process characterization and DOE-based development on new equipment and processes being transferred to manufacturing in order to assess capabilities and document current state and ultimately the validated state
· Lead Continuous Improvement and Lean Equipment practices such as - Quality/Yield improvement, set-up reduction, autonomous maintenance training and coaching, predictive maintenance, etc.
· Be part of quality investigations and use sound and established problem-solving methodologies such as 8D, 5-Whys, Fishbone Diagrams, etc.
· Provide input and feedback on the capacity and capability planning for the growing operations
· Co-author the strategic automation/equipment plan to enable QSI rapid scale-up
· Partner closely with equipment suppliers and third-party automation companies to source and install novel equipment to support capacity needs
· Other duties and contributions which are aligned with a high growth, rapidly scaling company on the verge of new discoveries resulting from the novel technology we are creating here at Quantum-Si.
· Applicants must have 5+ years’ experience in operations engineering or very related function
· Bachelor’s Degree in Engineering (Mechanical, Industrial, Biomedical, Chemical or Related Field) is required for consideration · Experience in reagent-focused consumable manufacturing within the life sciences industry
· Direct experience with Equipment Qualification (IQ/OQ/PQ) and Process Validation (PV)
· Strong and clear communicator with experience presenting concepts, experiments and results to direct and extended leadership
· Strong attention to detail.
· Clear and concise documentation in protocol preparation and execution
Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!):
· The ideal applicant would have direct involvement in the life sciences: medical diagnostics, genomics (or related omics) in both small and large companies in all aspects of the Product Development Process (PDP) lifecycles
· Additional desired experience related to the job function is:
· 6S/Lean/Six-Sigma Training
· Bio-processing & Formulation Experience
· Tube/Vial Fill & Finish Experience
· Packaging & Labeling Experience
The estimated base salary range for this role based in the United States of America is: $100,000- $130,000. Compensation decisions are dependent on several factors including, but not limited to, level of the position, an individual’s skills, knowledge and abilities, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all full-time employees are eligible for our discretionary bonus program and equity as part of the compensation package.
For this role, we provide visa assistance for qualified candidates.
Quantum-Si does not accept agency resumes.
Quantum-Si is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.