Bioworks Certification Jobs (NOW HIRING)

Make medicines better, faster, and more reliably. Join us as an MES Specialist I and own the endtoend design, configuration, testing, and lifecycle support of electronic Master Batch Records (eMBRs) in Werum PASX. You will translate manufacturing science into digital workflows that run our drug product operations—driving rightfirsttime execution, data integrity, and compliant performance.

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

• Design, configure, and maintain Master Batch Records in PASX aligned to defined manufacturing processes and regulatory requirements.
• Execute and document system testing and computer system validation deliverables to meet 21 Code of Federal Regulations Part 11, European Union Annex 11, and data integrity expectations.
• Define and manage batch components in the system, including materials, equipment, parameter sets, interlocks, electronic signatures, and workflow logic to ensure accurate and reliable execution.
• Gather user requirements with Manufacturing, Quality Assurance, Process Engineering, Validation, and Information Technology and translate them into functional digital workflows and clear acceptance criteria.
• Provide onfloor support during batch execution; troubleshoot electronic Master Batch Record performance and PASX functionality; implement timely fixes to maintain production continuity.
• Lead and contribute to continuous improvement initiatives that enhance electronic Master Batch Record design, reduce execution exceptions and downtime, and improve rightfirsttime performance.
• Participate in and, when appropriate, lead change control activities, deviation investigations, and impact assessments related to MES and eMBR updates.
• Maintain alignment with regulatory compliance and quality standards in all electronic documentation and configurations.
• Perform other duties, as assigned, to support reliable, compliant manufacturing.

What you’ll bring (minimum education and experience)

• High School Diploma or equivalent with 6+ years of applicable industry experience; OR
• Bachelor’s degree in Pharmaceutical Sciences, Biotechnology, Microbiology, or a closely related field with 2+ years of applicable industry experience; OR
• Master’s degree with no previous experience; OR
• Equivalent military experience or training.
• Experience in drug product manufacturing, sterile processing, or quality assurance.

Preferred education and experience

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 2+ years of experience in pharmaceutical manufacturing or MES (preferably PASX).
• Strong understanding of drug product processes such as formulation, filling, lyophilization, inspection, and packaging.
• Proficiency with PASX Master Batch Record design tools and configuration libraries.

Training or certification

• Preferred: Bioworks certificate

Skills that set you up for success

• Strong proficiency with PASX Master Batch Record design tools and configuration libraries.
• Indepth knowledge of current Good Manufacturing Practice regulations and electronic records/electronic signatures compliance.
• Working knowledge of drug product unit operations (formulation, aseptic filling, lyophilization, inspection, packaging).
• Ability to identify, quantify, and implement continuous improvements that reduce exceptions and downtime and improve rightfirsttime performance.
• Clear, organized documentation skills, including configuration specs, workflow diagrams, and decision records for audit readiness and knowledge transfer.
• Mentorship mindset to guide junior team members on configuration practices, testing methods, and compliance expectations; strong reviewer of work products for consistency and quality.
• Proven project and time management: plan work, set priorities, meet timelines, and deliver results while maintaining compliance rigor.

Why you’ll love it here

• Make a direct impact on patientcritical medicines by turning process science into reliable digital execution.
• Join a growthminded team that values curiosity, ownership, and continuous improvement.
• Collaborate across Manufacturing, Quality, Engineering, Validation, and IT while owning meaningful, endtoend solutions.

Work model and schedule

• This role supports manufacturing operations; occasional onfloor and offshift support may be required during batch execution or system releases.

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).