Sr. Specialist 1, QC Instrumentation

The QC Instrumentation Specialist will work independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role will ensure compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role will ensure the performance of routine maintenance, completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role will also support stakeholders with issues and guidance related to QC analytical instruments. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. This role is included in routine on-call and weekend support, as needed.

Company Overview

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Job Description

What You’ll Do

• Execute the qualification, routine operation, maintenance, continuous improvement and decommissioning of QC analytical instrumentation.
• Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.
• Author and review SOPs, technical reports, user requirements and functional specifications, and KNEAT protocols and reports.
• Support data integrity initiatives related to analytical instruments.
• Recommend appropriate user roles and privileges for data integrity (where applicable), write instrument operation instructions and preventative maintenance plans.
• Work with vendors performing maintenance activities on QC analytical instruments.
• Complete periodic reviews of QC instruments and associated instrument control software.
• Identify and follow-up on excursions and deviations and initiate corrective and preventative actions (CAPAs) related to analytical instruments.
• Support stakeholders, including end users, with issues and guidance related to QC analytical instruments.
• Work cross functionally with all end users, Validation Team, Labware Specialists, and Quality Assurance.
• Performs other duties, as assigned
  
  

Minimum Requirements:

• Bachelor’s degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 3 years of relevant experience OR
• Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 1 year of relevant experience
• 1- 3 years relevant experience, experience in a GMP environment
  
  

Preferred Requirements:

• Experience with KNEAT software
• Experience qualifying analytical instruments
• Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.
  
  

Working Conditions & Physical Requirements:

• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc
• Ability to stand for prolonged periods of time, up to 60 minutes
• Ability to sit for prolonged periods of time, up to 60 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and using twisting motions
• Will work in small and/or enclosed spaces
• Will work in heights greater than 4 feet
  
  

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).