50 applicants

Company

Original Job Post

CARsgen Therapeutics · 2 days ago

Process Engineer II

Durham, NC

Full-time

Onsite

Mid Level

3+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

Health DiagnosticsMedical

H1B Sponsorship

Hiring Manager

Vera Yang

Insider Connection @CARsgen Therapeutics

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Coordinate maintenance activities with internal stakeholders and vendors within a GMP process facility.

Thoroughly review controlled documentation for clarity and traceability.

Assist in the development and maintenance of standard operating procedures (SOP) and equipment forms/logbooks for the department.

Maintain CMMS (Blue Mountain Regulatory Asset Manager) assets, PM schedule, maintenance work orders and associated documentation.

Maintain Vaisala Environmental Monitoring System.

Maintain facility drawings (P&ID’s, Floorplans, etc.).

Assist with investigations and action items to support Deviations, CAPA’s, and Change Controls.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Maintenance principlesCleanroom experienceGMP knowledgeTroubleshootingFacility maintenanceEquipment maintenanceCMMS experienceQMS framework experienceDeviation handlingOOT handlingCAPA handlingChange Control handlingCommunicationOrganizationalFlexibilityAnalyticalTechnicalEthicsAutoCADDrawing Management

Required

Bachelor’s degree in engineering or life science related field and a minimum of three years of experience in a GMP manufacturing environment

Coordination experience and knowledge of maintenance principles within a manufacturing and GMP process facility

Previous experience working in a cleanroom or GMP/regulated manufacturing environment

Strong communication and organizational skills

Flexibility to perform various tasks and ability to prioritize based on business needs

Analytical and technical skills to work through and troubleshoot equipment and instruments

Experience maintaining supportive facility & utility equipment in a GMP regulated facility

Experience with GMP process and analytical equipment such as incubators, refrigerators and freezers, biological safety cabinets, small bioreactors, centrifuges

Experience working with a CMMS (Blue Mountain, SAP, Maximo, etc) and managing maintenance work orders and associated documentation

Previous experience handling Deviations, OOT, CAPAs, and Change Controls for equipment within a QMS framework

Ethics and Integrity

Preferred

Experience with AutoCAD for drawing management is a plus

Company

CARsgen Therapeutics

CARsgen is a leading immunotherapy company focused on the development of new chimeric antigen receptor

Founded in 2014

Shanghai, Shanghai, CHN

501-1,000 employees

http://www.carsgen.com

H1B Sponsorship

CARsgen Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (2)

2021 (2)