Senior Process Engineer

3 weeks ago


Holly Springs North Carolina, United States Fujifilm Full time
About the Role

This position reports to the Director of Process Engineering in support of the Process Equipment team. The successful candidate will support the Aura project, a greenfield expansion construction project. The initial assignment will be to assume the Responsible Engineer role for the Product Hold unit operation.

Key Responsibilities
  • Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider for high complexity equipment packages.
  • Ensures on-time delivery and quality from Fujifilm and EPC provider for high complexity equipment packages.
  • Develops and aligns high complexity plans and provides mitigations, as needed.
  • Reviews piping and instrumentation diagrams (P&IDs) and other process design documents.
  • Provides direction to detailed design activities in partnership with the EPCM provider.
  • Writes User Requirement Specifications (URSs).
  • Supports Factory Assessment Tests (FATs), Commissioning, Qualification and Validation (CQV), and start-up activities.
  • Serves as on-call support for process equipment.
  • Reviews, redlines, and approves P&IDs and other technical documents, as the technical authority.
  • Leads system impact assessments and quality risk assessments for process equipment.
  • Performs technology transfer (TT) activities related to process equipment.
  • Supports execution of Good Manufacturing Practices (GMP) runs.
  • Provides technical support for root cause analysis (RCA) and process deviation investigations.
  • Leads deviation and corrective and preventive action (CAPA) closures.
  • Makes decisions regarding technical risk assessments for new manufacturing equipment.
  • Provides on-floor manufacturing support for equipment issues.
  • Provides process equipment training and consultation on topics within assigned area.
  • Identifies continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield, and cost.
  • Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification.
  • Conducts training and presents information to team or other stakeholders.
  • Cross-trains on unit operations to assist team with achieving deliverables.
  • Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation.
Requirements
  • Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 8 years of Engineering or other relevant technical experience; or
  • Master's degree in Chemical or Biotechnology Engineering with 6 years of Engineering or other relevant technical experience.
  • Experience in Life Science or other regulated industry.
  • Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system).
  • Proficient experience in multiple unit operations within the assigned plant section.
Preferred Requirements
  • Prior experience working in a cGMP environment or other highly regulated industry.
  • Experience with large-scale mammalian cell culture processes, ≥ 2000L.
  • Large-scale capital project experience, > $500M USD.


  • Holly Springs, United States Amgen Full time

    Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on...


  • Holly Springs, Georgia, United States Fujifilm Corporation Full time

    Job SummaryThis is a challenging opportunity for a highly skilled Process Engineer to join our team at Fujifilm Corporation. As a key member of our Process Engineering team, you will be responsible for supporting the Aura project, a greenfield expansion construction project in Holly Springs, NC. Your primary focus will be on assuming the Responsible Engineer...


  • Holly Springs, Georgia, United States Fujifilm Corporation Full time

    Job SummaryThis role reports to the Director of Process Engineering and supports the Process Equipment team. The primary responsibility is to assume the Responsible Engineer role for the Product Hold unit operation in the Aura project, a greenfield expansion construction project in Holly Springs, NC.Key ResponsibilitiesServes as the point of contact for high...


  • Raleigh, North Carolina, United States ITAC Full time

    About ITACITAC is a leading provider of integrated engineering and construction services for complex capital projects. With a nationwide footprint and over 450 employees, we offer innovative design-build solutions to Fortune 500 companies across various industries.Job SummaryWe are seeking a highly experienced Senior Process Engineer to join our team. As a...


  • Holly Springs, United States Amgen Full time

    Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...

  • Senior Engineer

    2 months ago


    Holly Springs, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...


  • Belmont, North Carolina, United States Textum Full time

    Job Title: Senior Materials and Process EngineerTextum OPCO, LLC is seeking a highly skilled Senior Materials and Process Engineer to join our team in Belmont, NC. As a key member of our textile manufacturing operation, you will be responsible for designing, building, and maintaining mechanical systems, as well as interfacing with vendors, technicians, and...


  • Hickory, North Carolina, United States Computer Task Group, Inc Full time

    Job DescriptionJob Summary:We are seeking a highly skilled Senior Process Engineer to join our team at Computer Task Group, Inc. As a key member of our manufacturing operations team, you will be responsible for providing hands-on support for the installation, start-up, and debugging of high-speed cable manufacturing process equipment.Key...


  • Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking a Senior Automation Engineer to join a pharmaceutical manufacturing facility that is brand new and going to be the largest end-to-end cell manufacturing facility in Northern America.. The Senior Automation Engineer will be serving as a SME supporting the design and implementation of automation processes. This is...


  • Holly Springs, United States Zachary Piper Solutions, LLC Full time

    Piper Life Sciences is actively seeking a Senior Automation Engineer to join a pharmaceutical manufacturing facility that is brand new and going to be the largest end-to-end cell manufacturing facility in Northern America.. The Senior Automation Engineer will be serving as a SME supporting the design and implementation of automation processes. This is a...


  • Holly Springs, North Carolina, United States Fujifilm Full time

    About the RoleThis position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team. The initial assignment is to assume the Responsible Engineer role for Media and Buffer Prep unit operations.Key ResponsibilitiesServes as point of contact to the Engineering, Procurement, Construction Management (EPC) providerSecures...


  • Holly Springs, Georgia, United States Piper Companies Full time

    Piper Life Sciences Seeks Senior Automation EngineerPiper Life Sciences is actively seeking a highly skilled Senior Automation Engineer to join our team at our state-of-the-art pharmaceutical manufacturing facility in Holly Springs, NC. As a Senior Automation Engineer, you will play a key role in supporting the design and implementation of automation...


  • Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Quality Assurance Senior Engineer, DSM Disposition, is a critical position responsible for establishing and maintaining a robust and efficient disposition program at our site. This role ensures the quality and compliance of product disposition and identifies opportunities for continuous improvement.Key ResponsibilitiesPerform and manage...


  • Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Quality Assurance Senior Engineer, DSM Disposition, is a critical position responsible for establishing and maintaining a robust and efficient disposition program at our manufacturing site.This role ensures the quality and compliance of product disposition and identifies opportunities for continuous improvement. The successful candidate...


  • Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Senior Automation Engineer provides support to the Drug Substance Manufacturing (DSM) facility and leads the Automation activities associated with the site expansion with two additional DSM buildings. This includes implementation of changes to the Automation systems, updating design documents, executing testing, and troubleshooting...


  • Raleigh, North Carolina, United States ITAC Full time

    Company OverviewITAC is a leading provider of integrated engineering and construction services tailored for Process & Industrial clients, focusing on complex capital projects. We have a rich history since our inception in 1988, evolving from a modest beginning into an ENR-Ranked Top Design Firm, employing over 450 professionals across multiple states.Our...


  • Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Senior IT Engineer 1, Business Relationship Partner serves as the site liaison between Fujifilm Global IT and Fujifilm, Holly Springs. This role is responsible for driving collaboration with business units to ensure IT aligns with local site goals.Key ResponsibilitiesAnalyzes business requirements and works with local IT leadership to...


  • Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Senior Quality Engineer, Supplier Oversight, plays a critical role in ensuring that suppliers of services or materials to Fujifilm Diosynth Biotechnologies meet the highest quality standards while conforming to pre-established requirements, including cGMPs.Key ResponsibilitiesPrepare, conduct, and report results of audits of GMP service...

  • Senior Engineer

    6 days ago


    Holly Springs, Georgia, United States National Guard Employment Network Full time

    Job Title: Senior EngineerJoin our team of innovative professionals at National Guard Employment Network as a Senior Engineer in Global Engineering. We are seeking a collaborative individual with a strong background in engineering to lead our initiatives in reducing carbon footprint, water consumption, and waste generation.Job SummaryWe are looking for a...


  • Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Senior Quality Engineer, Supplier Management, plays a critical role in ensuring that suppliers of services or materials to Fujifilm Diosynth Biotechnologies meet the highest quality standards while conforming to pre-established requirements, including cGMPs.Key ResponsibilitiesPrepare, conduct, and report results of audits of GMP service...