Full-Time

Staff Manufacturing Engineer

Posted on 4/27/2024

Cellares

51-200 employees

Automated cell therapy manufacturing platform

Data & Analytics

Hardware

Senior, Expert

San Bruno, CA, USA

Required Skills

SolidWorks

Requirements

BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
10-15 years of extensive, hands-on experience in biotech automation, semiconductor or similar industries
Work history with several successful transfers of highly automated equipment to CM
Excellent verbal, written, presentation and interpersonal skills
Strong analytical and problem-solving skills
Experience with a wide variety of manufacturing techniques including hands-on experience with machine shop equipment
Prior experience with FDA regulations and ISO, cGMP, QMS standards is a plus
Knowledge of GD&T as well as proficiency with SolidWorks
Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
Self-awareness, integrity, authenticity, and a growth mindset

Responsibilities

Responsible for overseeing manufacturing activities at Contract Manufacturer
Work closely with CM to solve any technical or supplier issues
Drive End of Line (EOL) acceptance testing criteria
Assist in troubleshooting technical issues at CM and in the field
Develop, document, and follow standard operating procedures and work instructions
Develop and manage manufacturing documentation framework/templates
Investigate nonconformances and deviations at component and subsystem level
Initiate and process engineering, document, and ERP system changes
Collaborate with design engineers on early-stage hardware development with a focus on manufacturability, process capability, design scalability, and total cost
Review engineering drawings to ensure drawing definition is optimized for manufacturability
Generate complete documentation packets and transfer products to contract manufacturers

Position Summary

We are seeking an innovative and highly motivated Staff Manufacturing Engineer, who will contribute significantly to the manufacturing of equipment used to produce cell therapy solutions. This position will report to the Director of Engineering.

The primary focus of this position will be to drive the manufacturing effort at our Contract Manufacturer and act as a liaison between our internal Engineering team and the CM. As a Staff Manufacturing Engineer, you will take ownership of a wide range of tasks pertaining to the fabrication, assembly and test of multiple subsystems. During this process, you will be required to provide schedule updates, mitigation plans, assist CM with troubleshooting and end of line testing.

This is a multidisciplinary role & this individual will interface across many parts of the company (engineers, installers, field service) to ensure the manufacturability and scalability of the best solutions possible. The successful candidate will be experienced in the areas of mechanical design, fluidic control, and highly automated instrument development. This is a hands-on position.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

Responsible for overseeing manufacturing activities at Contract Manufacturer
Work closely with CM to solve any technical or supplier issues
Drive End of Line (EOL) acceptance testing criteria
Assist in troubleshooting technical issues at CM and in the field
Develop, document, and follow standard operating procedures and work instructions
Develop and manage manufacturing documentation framework/templates
Investigate nonconformances and deviations at component and subsystem level Initiate and process engineering, document, and ERP system changes
Collaborate with design engineers on early-stage hardware development with a focus on manufacturability, process capability, design scalability, and total cost
Review engineering drawings to ensure drawing definition is optimized for manufacturability
Generate complete documentation packets and transfer products to contract manufacturers

Requirements

BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience 10-15 years of extensive, hands-on experience in biotech automation, semiconductor or similar industries
Work history with several successful transfers of highly automated equipment to CM
Excellent verbal, written, presentation and interpersonal skills
Strong analytical and problem-solving skills
Experience with a wide variety of manufacturing techniques including hands on experience with machine shop equipment
Prior experience with FDA regulations and ISO, cGMP, QMS standards is a plus
Knowledge of GD&T as well as proficiency with SolidWorks
Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
Self-awareness, integrity, authenticity, and a growth mindset

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

Cellares

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Website

View Company Profile

Cellares specializes in advanced cell therapy manufacturing with its proprietary Cell Shuttle platform. This platform exemplifies industry leadership by integrating state-of-the-art automation and software solutions, significantly reducing process failure rates and costs. Working at this company provides the unique opportunity to contribute to life-saving innovations while being part of a culturally rich environment that collaborates with top-tier academic and industry partners worldwide.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights

Headcount

6 month growth

↑ 19%

1 year growth

↑ 46%

2 year growth

↑ 95%