Computer System Validation Csv Jobs in Raleigh, NC

Own the end-to-end design, configuration, testing, and lifecycle support of electronic Master Batch Records (eMBRs) in Werum PAS-X. As an MES Specialist I, you will translate manufacturing science into digital workflows that power our drug product operations-driving right-first-time execution, data integrity, and compliant performance in a dynamic, 24/7 environment.

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

What you'll do

• Support operational readiness during project phases, including site commissioning and qualification efforts.
• Act as a process subject matter expert (SME) to troubleshoot and resolve issues across assigned process areas.
• Coordinate Batch Planning, including process template creation/import and Preventive Maintenance (PM) management.
• Own and drive major documentation updates; initiate new documents to support new processes.
• Coordinate non-batch activities such as changeovers, PMs, and Aseptic Process Simulations (APS).
• Partner with MSAT to support technology transfer into manufacturing.
• Champion compliance and safety, ensuring procedures are followed in the manufacturing environment.
• Create and update Electronic Batch Records (EBRs/eMBRs) in PAS-X and support Paper Batch Records as needed.
• Manage, perform, initiate, or support quality system records, including change controls, investigations, CAPAs, and Continuous Improvement (CI) activities.
• Lead and participate in projects within Drug Product Finished Goods; manage execution to plan.
• Support internal and external inspections and audits to maintain a state of compliance.
• Assist the Manager with projects, training, onboarding, and knowledge transfer.
• Perform other duties as needed to meet production and compliance goals.

Note: This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

Minimum education and experience requirements

• High School Diploma or equivalent with 9 years of applicable industry experience; OR
• Bachelor's degree with 5 years of applicable industry experience; OR
• Master's degree with 3 years of applicable industry experience; OR
• PhD with no prior industry experience; OR
• Equivalent Military Experience
• High degree of understanding of operations sequence and the cadence of activities in a manufacturing environment

Minimum training/certifications: N/A

Preferred education and experience

• BioWorks or BTEC Capstone cGMP coursework preferred

What you'll bring

• Strong verbal and written communication skills; ability to effectively present information.
• Strong time management; able to prioritize and deliver in a fast-paced setting.
• Critical thinking and superior problem-solving skills.
• Ability to analyze and troubleshoot simple to moderate system and component issues.
• Ability to coordinate and facilitate effective small cross-functional teams.
• Mentorship mindset with the ability to guide junior associates.
• Team-based attitude; able to build relationships and work effectively in a global, cross-functional environment.

Ready to help transform how medicines are made-and make a measurable impact on patient outcomes? Apply today.

Equal opportunity We are an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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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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.

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).