Automation Engineer 2, CSV

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 7 days ago

Vacancies: 1 Vacancy

Department:

Automation Engineering

Job Summary

Position Overview

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll 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

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 partners

Basic Requirements

Bachelors 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 year of Automation experience

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

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 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 committedto 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 ().

Position OverviewThe 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 Aut...