What are the responsibilities and job description for the Automation Engineer 2, CSV position at FUJIFILM Biotechnologies?
The Automation Engineer 2, CSV will provide support to the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems, and being a part of Automation on-call support as needed. This role will partner with other departments locally and other sites to align strategies and procedures. 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.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers
Job Description
What You’ll Do
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 30 minutes
Ability to sit for prolonged periods of time. No X Yes 240 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers
Job Description
What You’ll Do
- Ensures that Computer System Validation is performed to a consistently high standard, within budget, and that objectives are met on time
- Provides plans for the qualification of the DSM area
- Participates in the development of documents, processes, and procedures of the CSV program
- Generates, reviews, and approves DSM Automation Computerized Systems lifecycle documentation (e.g. risk and impact assessments, requirement specifications, functional specifications, traceability matrices, commissioning and qualification protocols, validation plans, and validation summary reports)
- Helps to assess the impact of Computer System modifications through the change control process
- Helps to maintain the validation status of DSM Automation Computerized Systems
- Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices
- Serves as on-call support for CSV Automation inquiries and troubleshooting
- Other duties, as assigned
- 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 partners
- Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or other relevant field 2 years of Automation, Instrumentation & Controls, or other relevant technical experience
- 3 year of Automation experience
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 30 minutes
Ability to sit for prolonged periods of time. No X Yes 240 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
