Jobs
>
Alameda

    Process Engineer III - Alameda, United States - GeneFab

    GeneFab
    GeneFab Alameda, United States

    3 weeks ago

    Default job background
    Description
    GeneFab is seeking a highly motivated Process Engineer III / Sr.

    Process Engineer, Manufacturing Sciences and Technology to lead and support internal/external technology transfers and process support activities with high-level technical expertise from development into GMP manufacturing.

    This role will be responsible for overseeing and facilitating the transfer of new processes and technologies from developmental stages to manufacturing scale, ensuring seamless integration and optimal performance.

    The ideal candidate should be experienced in cell and gene therapy (autologous and allogeneic) processes and cGMP operations, and comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities.

    The candidate must collaborate effectively with cross-functional teams including Manufacturing Sciences and Technology, Supply Chain, QC, PD, AD, and Quality Assurance, as well as the Client to accomplish deliverables for GMP readiness.


    Key Responsibilities:
    Technology Transfer ManagementLead technology transfer projects, coordinating with cross-functional teams including Process Development and external partners.
    Develop and implement technology transfer plans, ensuring adherence to timelines and quality standards.
    Conduct risk assessments and development mitigations strategies for technology transfer activities.

    Lead technology transfer discussions between sending units (Process Development and external partners) and receiving units (Manufacturing, QA, QC, SC, AD).

    Responsible for authoring Manufacturing process descriptions, engineering protocols, technical reports, and material specifications. Reviewing and approving manufacturing batch records and any other relevant document to support successful transfer. Create feasibility/gap assessments and facility fit analysis for new products and processes.


    Key Responsibilities:
    Process Optimization & Continuous ImprovementEvaluate manufacturing processes and identify areas for improvement. Propose and implement innovative solutions to enhance process robustness and scalability.
    Implement process enhancements to increase efficiency, reduce costs, and improve product quality.
    Participate in continuous improvement initiatives within MSAT and Manufacturing departments.
    Supervise/conduct lab work to resolve investigations and/or to demonstrate proof-of-concept for proposed changes.


    Key Responsibilities:
    Manufacturing Process SupportSupport process deviation investigations, root cause analyses, and CAPAs.
    Train manufacturing staff on new processes and technologies.


    Qualifications:


    Bachelor's or Masters in a relevant field (e.g., Engineering, Biotechnology, Molecular Biology).A minimum of 5-7 years of relevant experience in biopharmaceutical process engineering, with a focus on cell and gene therapy.

    Proven experience in technology transfer, process development, and GMP manufacturing.
    Experience with viral vector manufacturing, cell therapy, and mRNA is a plus.
    Strong communication and project management skills, with a commitment to cross functional collaboration.
    Knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA) and a track record of ensuring compliance.
    Basic understanding of lifecycle management of clinical and commercial manufacturing processes.
    Ability to analyze and interpret data and contextualize with the program goals and requirements in a phase-appropriate manner.$125,000 - $155,000 a yearSalary is DOE
  • GeneFab

    Process Engineer III

    3 weeks ago

    GeneFab Alameda, United States

    GeneFab is seeking a highly motivated Process Engineer III / Sr. Process Engineer, Manufacturing Sciences and Technology to lead and support internal/external technology transfers and process support activities with high-level technical expertise from development into GMP manufac ...

  • GeneFab

    Process Engineer III

    2 days ago

    GeneFab Alameda, United States

    GeneFab is seeking a highly motivated · Process Engineer III / Sr. Process Engineer, Manufacturing Sciences and Technology · to lead and support internal/external technology transfers and process support activities with high-level technical expertise from development into GMP m ...

  • Penumbra

    Quality Engineer III

    3 weeks ago

    Penumbra Alameda, United States

    General SummaryIndependently develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance to applicable regulations and standards. Work with problems of advanced scope where the analysis of sit ...

  • Penumbra

    Quality Engineer III

    3 weeks ago

    Penumbra Alameda, United States

    General Summary · Independently develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance to applicable regulations and standards. Work with problems of advanced scope where the analysis of ...

  • Knewin

    Quality Engineer III

    2 weeks ago

    Knewin Alameda, United States

    General Summary · Independently develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance to applicable regulationsand standards. Work with problems of advanced scope where the analysis of s ...

  • Altais

    Data Engineer III

    3 weeks ago

    Altais Oakland, United States

    Job Description · Job DescriptionAbout Our Company · At Altais, we're looking for bold and curious innovators who share our passion for enabling better health care experiences and revolutionizing the healthcare system for physicians, patients, and the clinical community. Doctors ...

  • E Tech Group

    Automation Engineer III

    2 weeks ago

    E Tech Group Oakland, United States

    Job Description · Job DescriptionAt E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and co ...

  • Pulmonx Corporation

    Quality Engineering Technician Iii

    3 days ago

    Pulmonx Corporation Redwood City, United States

    **Pulmonx** is looking for a **Quality Engineering Technician III** to join and our team Who is **Pulmonx**? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · **Resp ...

  • Bruker

    Applications Engineer III

    2 weeks ago

    Bruker Emeryville, United States

    Applications Engineer III · Job Locations · US-CA-Emeryville · Req. # · # of Openings · 1 · Position Type · Employee · Overview · At Bruker Cellular Analysis (BCA), we create products using advanced optofluidic technology that enable customers to screen the function of i ...

  • Bruker

    Applications Engineer III

    3 weeks ago

    Bruker Emeryville, CA, United States

    · Applications Engineer III · Job Locations · US-CA-Emeryville · Req. # · # of Openings · 1 · Position Type · Employee · Overview · At Bruker Cellular Analysis (BCA), we create products using advanced optofluidic technology that enable customers to screen the function of individ ...

  • Bruker

    Applications Engineer III

    3 weeks ago

    Bruker Emeryville, United States

    Overview · At Bruker Cellular Analysis (BCA), we create products using advanced optofluidic technology that enable customers to screen the function of individual cells and recover cells of interest for downstream application. For example, our Opto B Discovery workflows screen ten ...

  • Google

    Software Engineer Iii, Machine Learning,

    1 week ago

    Google Mountain View, United States

    **Minimum qualifications**: · - Bachelor's degree or equivalent practical experience. · - 2 years of experience with software development in one or more programming languages, or 1 year of experience with an advanced degree in an industry setting. · - 2 years of experience with d ...

  • Wilson Workforce Solutions LLC

    Engineer III

    3 weeks ago

    Wilson Workforce Solutions LLC West Valley City, United States

    About the job Engineer III · By joining a team of more than 11,000 people working across more than 60 countries, you will be part of an agile network of talented and ambitious people. In fact, we count on you to engage, connect and collaborate with colleagues all over the world. ...

  • Cowlitz County

    Engineer III

    3 days ago

    Cowlitz County San Francisco, United States

    Job Description · This is a professional civil engineering position that functions as a Civil Engineer for Cowlitz County. The position consists of two divisions that provide engineering and planning services for the Utilities and Stormwater Division, and the Diking and Developm ...

  • CrowdStrike Holdings, Inc.

    Engineer III

    2 weeks ago

    CrowdStrike Holdings, Inc. San Francisco, United States

    #WeAreCrowdStrike and our mission is to stop breaches. As a global leader in cybersecurity, our team changed the game. Since our inception, our market leading cloud-native platform has offered unparalleled protection against the most sophisticated cyberattacks. We work on large s ...

  • Cowlitz County

    Engineer III

    6 days ago

    Cowlitz County San Francisco, United States

    Job Description · This is a professional civil engineering position that functions as a Civil Engineer for Cowlitz County. The position consists of two divisions that provide engineering and planning services for the Utilities and Stormwater Division, and the Diking and Developm ...

  • Sutter Health

    Cybersecurity Engineer III Privileged Access Management

    4 days ago

    Sutter Health Alameda, United States

    We are so glad you are interested in joining Sutter Health · Organization: · SHSO-Sutter Health System Office-Valley · Position Overview: · This role will develop and build security controls, administer security technology solutions to reduce risk and/or ensure rapid delivery of ...

  • Sherwoodengineers

    Design Engineer III

    3 weeks ago

    Sherwoodengineers San Francisco, United States

    Design Engineer III Civil Engineering - Careers at Sherwood Design Engineers · Career Opportunities with Sherwood Design Engineers · Careers at Sherwood Design Engineers · Current job opportunities are posted here as they become available. · Back To Openings · Design Engineer ...

  • Syska Hennessy

    Electrical Engineer III

    1 week ago

    Syska Hennessy San Francisco, United States

    As an Electrical Engineer III- IV you will be responsible for creating basic designs under the direction of senior engineers and/or senior designers, performing equipment selections, and load/energy and pressure drop calculations for a variety of pro Electrical Engineer, Engineer ...

  • PSG Global Solutions

    Engineering Technician III

    4 days ago

    PSG Global Solutions San Francisco, United States

    We're looking for an · Engineering Technician III , working in · Biotechnology/Medical Devices · industry in · 269 E Grand Avenue, South San Francisco, California, 94080, United States . · Manages and performs device QC testing of electronics assemblies to ensure compliance ...