Jobs
>
Raleigh

    Staff / Senior Process Engineer - Raleigh, United States - GRAIL, Inc.

    GRAIL, Inc.
    GRAIL, Inc. Raleigh, United States

    4 weeks ago

    Default job background
    Description

    ***WE STRONGLY ENCOURAGE OUR VETERAN COMMUNITY TO APPLY***

    The Staff/Sr Process Engineer will plan, develop, improve, organize, and implement the Equipment lifecycle program according to multiple regulatory bodies. They will also help improve our quality maturity in the engineering organization. This function will be responsible to reduce quality defects in our business and processes and provide practical GMP guidance and mentorship to our teams. The engineer will own and execute root-cause investigations, implement action plans for nonconformances, internal/external audits and other compliance related matters. GRAIL's processes are scaling fast and require a dynamic and detail oriented engineer to help deliver our revolutionary test to as many people as possible.

    Expected schedule is on-site Monday through Friday in Durham, NC (RTP Site)
    This position may need to support weekends and holidays.
    Alternative locations and work arrangements could be considered.
    Responsibilities;

    • Assure compliance with SOX, CLIA/CAP, FDA 21 CFR part 820, ISO 13485, IVDR requirements
    • Create and update work instructions, guidelines, verifications, and standard operating procedures (SOP)
    • Develop roadmaps and lead initiatives to ensure long term compliance sustainability
    • Leads CAPAs and associated quality investigations
    • Participate, be a role model, and adhere to GRAIL's policies and guidelines
    • Provide training, support in the creation of new training, and transfer knowledge
    • Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process
    • Supports audit readiness and on-site audits
    • Work closely with Quality and regulatory to implement and follow the required policies and procedures for the lifecycle of equipments
    • Anticipates and resolves conflict situations in a win - win outcome
    Preferred qualifications;
    • 5+ years of related experience with a BS/BA or higher degree in Engineering or Life Sciences or equivalent
    • Experience executing within a computerized maintenance/calibration management system, product lifecycle managements systems, and quality management systems
    • Experience working in a clinical laboratory regulated environment
    • Knowledge of lean tools and root cause analysis methodologies
    • Strong background in GMP manufacturing
    • Project management skills
    • Ability to work in a matrix organization
    • High emotional intelligence with proven ability to set a course and bring his/her peers forward with them.
    • Excellent communication skills to work as a leader, provide internal customer support, and influence other departments and individuals
    • Excellent time management skills to support a fast paced working environment
    • Strong leadership skills with demonstrated ability to effectively work across teams and functions
    • Highly Preferred:
    • Graduate degree in an engineering or scientific discipline
    • Veeva experience
    • Experience with Laboratory Information Management Systems (LIMS) and Manufacturing Management Systems (MES)
    • Ability to travel up to 15% of the time
    *For California based candidates;

    The expected, full-time, annual base pay scale for this position is$110, $138, Actual base pay will consider skills, experience, and location.
  • Integrated Project Services

    Lead Process Engineer

    2 weeks ago

    Integrated Project Services Raleigh, United States Regular Full time

    Job Description · At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people by solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a dedicated Lead ...

  • Believer Meats

    Food Process Engineer

    6 days ago

    Believer Meats Raleigh, United States

    Believer Meats is an innovative start-up revolutionizing the food industry through the development and commercialization of cultivated meat products. Leveraging cutting-edge biotechnology, we aim to provide sustainable, ethical, and high-quality meat alternatives to consumers wor ...

  • Page Southerland Page

    Senior Process Engineer

    1 week ago

    Page Southerland Page Raleigh, United States Permanent

    Overview · At Page, we promise design that makes lives better. We're actively seeking talented people to join an empowered employee environment. Page provides architecture, engineering, interiors and consulting services on large, complex projects around the world. We credit the ...

  • Schneider Electric

    Assembly Process Engineering

    2 weeks ago

    Schneider Electric Raleigh, United States

    What do you get to do in this position?Participate as a team of assembly engineering specialists to industrialize assembly processes for new product developmentWork directly with Designers and Engineers to optimize part design for design for assembly (DFA)Conduct Process Failure ...

  • SpiraTec AG

    Manufacturing Process Automation Engineer

    1 week ago

    SpiraTec AG Raleigh, United States

    · Manufacturing Process Automation Engineer (hybrid/remote) at SpiraTec AG | softgarden · View job here Manufacturing Process Automation Engineer (hybrid/remote) · Full Time · Raleigh, North Carolina, USA · Hybrid · With Professional Experience · 5/29/24 · Contact person · Rec ...

  • SpiraTec AG

    Manufacturing Process Automation Engineer

    2 weeks ago

    SpiraTec AG Raleigh, United States

    · Manufacturing Process Automation Engineer (hybrid/remote) at SpiraTec AG | softgarden · View job here Manufacturing Process Automation Engineer (hybrid/remote) · Full Time · Raleigh, North Carolina, USA · Hybrid · With Professional Experience · 4/29/24 · Contact person · Rec ...

  • LHH

    Process Engineer

    4 weeks ago

    LHH Raleigh, United States

    A multi-million-dollar global electronics manufacturer is looking to add a Process Engineer to their strong Raleigh team This growing business prides themselves on operating at the highest level of innovation and quality in all of their products across various industries, and are ...

  • Piper Companies

    Process Engineer

    1 week ago

    Piper Companies Raleigh, United States

    Piper Companies is seeking a Process Engineer to join an innovative biotechnology organization that has recently relocated manufacturing to North Carolina. The Process Engineer will play a pivotal role in vendor and equipment selection, and the development of efficient, robust ma ...

  • LHH

    Process Engineer

    3 weeks ago

    LHH Raleigh, United States

    A multi-million-dollar global electronics manufacturer is looking to add a Process Engineer to their strong Raleigh team This growing business prides themselves on operating at the highest level of innovation and quality in all of their products across various industries, and are ...

  • Piper Companies

    Process Engineer

    2 weeks ago

    Piper Companies Raleigh, United States

    Piper Companies is seeking a Process Engineer to join an innovative biotechnology organization that has recently relocated manufacturing to North Carolina. The Process Engineer will play a pivotal role in vendor and equipment selection, and the development of efficient, robust ma ...

  • Southern Company

    Manufacturing Process Engineer II

    2 weeks ago

    Southern Company Raleigh, United States

    Job Summary: · The Manufacturing Engineer 2 (ME2) is responsible for ensuring efficient Methods of Manufacture (MoM's), Lean continuous process improvements and standardized work instructions are implemented. The ME2 promotes a lean manufacturing culture and works on improving t ...

  • ITAC

    Sr. Process Engineer, PE

    4 days ago

    ITAC Raleigh, United States Full time

    ITAC serves Process & Industrial clients with integrated engineering and construction services for complex capital projects. We also offer specialty services including power systems services and products, custom machine fabrication, and fall protection services and equipment. Fou ...

  • ITAC

    Sr. Process Engineer, PE

    1 day ago

    ITAC Raleigh, United States

    ITAC serves Process & Industrial clients with integrated engineering and construction services for complex capital projects. We also offer specialty services including power systems services and products, custom machine fabrication, and fall protection services and equipment. Fou ...

  • ITAC

    Sr. Process Engineer, PE

    3 days ago

    ITAC Raleigh, United States

    Job Description · Job DescriptionITAC serves Process & Industrial clients with integrated engineering and construction services for complex capital projects. We also offer specialty services including power systems services and products, custom machine fabrication, and fall prote ...

  • PowerSecure, Inc.

    Manufacturing Process Engineer II

    2 weeks ago

    PowerSecure, Inc. Raleigh, United States

    Job Description · Job DescriptionJob Summary: · The Manufacturing Engineer 2 (ME2) is responsible for ensuring efficient Methods of Manufacture (MoM's), Lean continuous process improvements and standardized work instructions are implemented. The ME2 promotes a lean manufacturing ...

  • TOPSYSIT

    Validation Engineer/Process Engineer

    2 weeks ago

    TOPSYSIT Raleigh, United States

    Job Title: Validation Engineer/Process Engineer · Client: Indivior · Location: 8900 Capitol Blvd, Raleigh, NC-27616 · Job Duties: · Review, develop and execute validation lifecycle documents like FAT, SAT and qualification protocols for new equipment and existing equipment enhanc ...

  • Page Southerland Page

    Senior Process Engineer

    3 weeks ago

    Page Southerland Page Raleigh, United States

    Overview: · At Page, we promise design that makes lives better. Were actively seeking talented people to join an empowered employee environment. Page provides architecture, engineering, interiors and consulting services on large, complex projects around the world. We credit the ...

  • Pond & Company

    Senior Process Engineer

    3 weeks ago

    Pond & Company Raleigh, United States

    About the Position · We are seeking a · Senior Process Design Engineer · to join our growing Process team in Peachtree Corners, GA The ideal candidate possesses over 6 years of Industrial Process design related experience. The ideal candidate would have extensive industrial ex ...

  • Piper Companies

    Utilities Process Engineer

    3 weeks ago

    Piper Companies Raleigh, United States

    Piper Companies is actively seeking a Utilities Process Engineer to join a global pharmaceutical organization that looks to provide solutions for chronic diseases. The Utilities Process Engineer will support new projects, equipment, and utilities throughout an API facility. The i ...

  • Piper Companies

    Utilities Process Engineer

    3 weeks ago

    Piper Companies Raleigh, United States

    Piper Companies is actively seeking a Utilities Process Engineer to join a global pharmaceutical organization that looks to provide solutions for chronic diseases. The Utilities Process Engineer will support new projects, equipment, and utilities throughout an API facility. The i ...