DeltaV Automation Engineer 2-CSV

3 days ago

Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About This Role

The Automation Engineer 2 will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support.

During the project phase, the main responsibility as a Computer System Validation (CSV) Automation Engineer 2 will be to prepare validation documentation and contribute to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems. This role will partner with other departments locally and other sites to align strategies and procedures. Once operational, this role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. Additionally, there will be involvement in facilitating improvement initiatives and supporting regulatory agency and third-party inspections.

What You’ll Do

  • Performs Automation activities, such as code configuration, document development, and test execution within several process areas
  • Delivers accurate and on-time Automation work
  • Creates standard code utilizing medium complexity control strategies
  • Collaborates with senior Engineers to develop (generate, review, maintain) various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
  • Collaborates with senior Engineers to develop (generate, review, maintain) various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
  • Serves as on-call support for Automation inquiries and troubleshooting
  • Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
  • Other duties, as assigned

Knowledge and Skills

  • Effective communication, both written and oral
  • Strong problem-solving skills
  • Ability to effectively present information to others
  • Ability to interpret and demonstrate knowledge of an Automation subject area to internal partner

Basic Requirements

  • Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or other relevant field
  • 2 years of Automation, Instrumentation & Controls, or other relevant technical experience

Preferred Requirements

  • 3+ years of Automation experience

  • Computer System Validation

    2 weeks ago

    Holly Springs, United States Saxon Global Full time

    ROLE - Computer System Validation (CSV) Automation Engineer WORK AUTH - All Except H1B RATE - $80/hr on C2C CLIENT- Mid-size Biotech organization (leader in the CDMO realm whose focus is to combine technical leadership in cell culture, microbial fermentation, and cell and gene therapy) HYBRID SCHEDULE 2-3 days on-site, Holly Springs, NC CONTRACT - 19-month...

  • Automation Engineer

    1 month ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking an 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 Automation Engineer will be assisting in automation systems projects involving technologies like in DeltaV, as well as serving as liasion...

  • Automation Engineer

    4 weeks ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking an  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  Automation Engineer  will be assisting in automation systems projects involving technologies like in  DeltaV, as well as...

  • Automation Engineer

    2 weeks ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking an 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 Automation Engineer will be assisting in automation systems projects involving technologies like in DeltaV, as well as serving as liasion...

  • Automation Engineer

    2 weeks ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking an 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 Automation Engineer will be assisting in automation systems projects involving technologies like in DeltaV, as well as serving as liasion...

  • Automation Engineer

    2 weeks ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking an  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  Automation Engineer  will be assisting in automation systems projects involving technologies like in  DeltaV, as well as...

  • Senior Automation Engineer

    1 month ago

    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 a...

  • Senior Automation Engineer

    4 weeks ago

    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....

  • Senior Automation Engineer

    2 weeks ago

    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 a...

  • Senior Automation Engineer

    2 weeks ago

    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....

  • Senior Automation Engineer

    2 weeks ago

    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 a...

  • Automation Systems Engineer: Biotech Innovations

    1 week ago

    Holly Springs, United States BioSpace, Inc. Full time

    About the RoleWe are seeking a highly skilled Automation Systems Engineer: Biotech Innovations to join our team at BioSpace, Inc.The successful candidate will have a strong background in automation engineering, with experience in designing and implementing complex systems for biopharmaceutical production.In this role, you will work closely with our team of...

  • Manufacturing Systems Engineer: Automation

    3 weeks ago

    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 four...

  • Manufacturing Systems Engineer: Automation

    2 weeks ago

    Holly Springs, United States BioSpace, Inc. Full time

    Job Details Join Amgens Mission of Serving Patients At 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...

  • Technical Lead

    1 week ago

    Holly Springs, United States FUJIFILM Corporation Full time

    About YouIf you're a seasoned Automation engineer with a passion for delivering high-quality results, we want to hear from you! As a Senior Automation Engineer 2, MES, you'll play a critical role in supporting Drug Substance Manufacturing (DSM) at FUJIFILM Diosynth Biotechnologies. Your primary responsibilities will include implementing changes to Automation...

  • Biopharmaceutical Automation Professional: Engineering Excellence

    1 week ago

    Holly Springs, United States BioSpace, Inc. Full time

    About the OpportunityThis is a unique chance to join a pioneering company in the biotech industry and contribute to groundbreaking research and development.You will work on high-profile projects, collaborating with cross-functional teams to design, implement, and optimize complex automation systems.The estimated salary for this position is $140,000 -...

  • Automation Specialist 2

    1 week ago

    Holly Springs, United States FUJIFILM Corporation Full time

    Overview:The FUJIFILM Diosynth Biotechnologies company is seeking a highly skilled and experienced individual to join our team as an Automation Engineer 2 in the DSM Downstream facility. This role plays a crucial part in ensuring the successful operation of our life science manufacturing facility and CDMO.The Automation Engineer 2 will be responsible for...

  • Senior System Engineer

    1 week ago

    Holly Springs, United States FUJIFILM Corporation Full time

    About UsFUJIFILM Diosynth Biotechnologies is a leading contract development and manufacturing organization (CDMO) providing high-quality biopharmaceutical products and services to clients globally. With over 30 years of experience, we have established ourselves as a trusted partner for companies seeking reliable and efficient solutions for their...

  • Senior Systems Engineer/Developer

    4 weeks ago

    Holly Springs, United States RoviSys Full time

    Overview Works directly with customers to define functional requirements and design, configure, commission and qualify control systems & software programs. ResponsibilitiesWork in team environment with engineers and designers from RoviSys, partners and clients to provide state of the art Control Systems to improve efficiency, product quality, and...

  • Automation Specialist

    1 week ago

    Holly Springs, United States FUJIFILM Corporation Full time

    Job DescriptionIn this role as an Automation Specialist at FUJIFILM Diosynth Biotechnologies, you will be responsible for implementing changes to automation systems, updating design documents, executing testing, troubleshooting events, and providing on-call support. This position requires strong problem-solving skills, effective communication, and the...