Senior Specialist 1, Quality Control Instrumentation

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:

Overview

Be the driving force behind world-class quality. As a Sr. Specialist I, QC Instrumentation, you will independently own the life cycle of QC analytical instruments-from qualification to decommissioning-ensuring they operate flawlessly, meet data integrity expectations, and stay in full compliance with regulatory requirements. If you're passionate about elevating lab performance, partnering cross-functionally, and solving complex instrumentation challenges, this role is for you.

Note: This position may require routine on-call and weekend support as needed.

External US

What You'll Do

You'll lead critical instrumentation initiatives that keep our QC operations accurate, compliant, and inspection-ready:

• Lead the execution of qualification, maintenance, continuous improvement, and decommissioning of QC analytical instruments, applying deep expertise in instrumentation, validation, and regulatory compliance.
• Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.
• Author and critically evaluate SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports to ensure accuracy, completeness, and regulatory alignment.
• Champion data integrity initiatives for analytical instruments, safeguarding data reliability and compliance.
• Review and recommend appropriate user roles and privileges for data integrity (where applicable); write instrument operation instructions and preventive maintenance plans.
• Coordinate with vendors to ensure effective maintenance and optimal performance of analytical instruments.
• Complete periodic reviews of QC instruments and associated instrument control software.
• Proactively identify and address excursions and deviations; initiate effective CAPAs to maintain instrument integrity and compliance.
• Support stakeholders and end users with issue resolution and expert guidance related to QC analytical instruments.
• Work cross-functionally with end users, the Validation team, Labware Specialists, and Quality Assurance.
• Perform other duties, as assigned.

Minimum Education and Experience Requirements

• Bachelor's degree in a science discipline (preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences) with 2+ years of relevant experience; OR
• Master's degree in a science discipline (preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences) with 0 years of relevant experience.
• 1-3 years of relevant experience, including experience in a GMP environment.

Preferred Qualifications

• Hands-on experience with analytical instrumentation such as:
• UPLC/HPLC
• Capillary electrophoresis/imaged capillary isoelectric focusing
• Gel electrophoresis/Western blot
• Plate readers
• qPCR
• Spectrophotometry
• Mass spectrometry
• Experience with KNEAT software.
• Experience qualifying analytical instruments.

Knowledge, Skills, and Abilities

• Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Strong cross-functional collaboration skills and the ability to build effective partnerships.
• Excellent verbal and written communication with exceptional attention to detail.
• Thorough understanding of pharmaceutical/biotech testing.
• Proven ability to interpret and implement data integrity standards and regulations.
• Demonstrated experience conducting investigations and writing deviations and CAPAs.
• Superior technical writing and problem-solving skills.
• Comfortable thriving in a fast-paced, highly technical environment.
• Ability to perform routine on-call and weekend support, as needed.

Why You'll Love This Role

• Make a high-impact contribution to product quality and patient safety.
• Own end-to-end instrumentation life cycle and drive meaningful continuous improvements.
• Collaborate with a talented, mission-driven team across QC, Validation, QA, and Labware.

Ready to raise the bar for QC instrumentation? Apply today and help advance reliable, compliant, and cutting-edge testing.

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.

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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 (View email address on hirelifescience.com).