Sr Hardware & Automation Engineer - Biotechnology

职位描述

We are seeking a highly motivated individual with automation and hardware development experience to join our team as a Senior Hardware Engineer to contribute toward the advancement of innovative T-cell therapy programs and technologies for cancer treatment at Kite’s Foster City, CA facility. The Hardware Engineer will be responsible for leading the design, prototyping, and testing of hardware systems and subsystems to support the development of next generation cell therapy manufacturing processes. They will influence system and equipment design decisions through technology evaluation activities, write and/or review user requirements, functional requirement specifications, qualification protocols, user acceptance tests and reports, and provide technical assessments, rationales, and approvals for design changes to meet internal and regulatory requirements. You will work independently as a hardware expert and actively partner with stakeholders across functions including Process Development, Analytical, IT, and others.

To foster collaboration and support relationship building this role is hybrid with at least 3 days a week in the office.

Responsibilities:

•    Lead the design, prototyping, and implementation of hardware systems to improve or enhance cell therapy processing equipment and workflows.

•    Collaborate closely with internal teams and vendors to develop solutions to enable robust reliability and quality testing of new equipment and associated single use/disposable kits.

•    Contribute to operationalizing new process technology by ensuring it meets requirements for safety and reliability

•    Participate in mentoring new team members and help foster culture that is helpful, inclusive, and fun

•    Define, manage, and communicate project timelines and risks

•    Proactively seek opportunities to automate and make cell therapy bioprocessing techniques and workflows more efficient.

Requirements:

•    PhD degree in Electrical or Computer Engineering with 0+ years of related experience or

•    MS degree in Electrical or Computer Engineering with 6+ years of related experience or

•    BS degree in Electrical or Computer Engineering with 8+ years of related experience or

•    High School Diploma with 12+ years of related experience

Preferred Qualifications:

•    Experience with mechanical and electrical system development, prototyping, assembly, and testing techniques

•    Excellent verbal, written, and interpersonal communication skills

•    Experience creating fixtures and diagnostic tools for component level testing

•    Experience with electrical system and integrated circuit design, familiarity with good EMI/EMC practices

•    Experience with at least one modern object-oriented language such as C# or Java

•    Proficient with 3D CAD and PCB design software such as SolidWorks, Altium, or EAGLE

•    Experience working with API documentation to integrate hardware or software systems

•    Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11 compliance

•    Experience with SCADA-Supervisory Control and Data Acquisition

•    Knowledge and understanding of biopharma processes or analytical techniques is a plus