Automation Engineer 2, CSV
About The Position
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
Requirements
- 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
Nice To Haves
- 3+ year of Automation experience
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
