The Manufacturing Support Associate 3 plays a crucial role in maintaining compliant and reliable production, with adhering to cGMP regulations and industry guidelines. This position leads compliance initiatives, oversees corrective and preventive action (CAPA) execution, and coordinates batch planning, all while ensuring seamless tech transfer and effective troubleshooting as a process subject matter expert (SME). The role demands flexibility in working hours to effectively support 24/7 production and accommodate inspections and audits.

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.

What You’ll Do

• Collaborates with stakeholders to implement compliance initiatives and carry out regulatory assessments, ensuring full alignment with industry standards and organizational goals
• Promotes a robust organizational structure by effectively overseeing CAPA execution and compliance monitoring to maintain high performance standards, while developing and implementing risk mitigation strategies
• Provides expert guidance on regulatory changes and industry trends
• Serves as a liaison between regulatory bodies and internal teams
• Collaborates effectively with cross-functional stakeholders to coordinate and execute comprehensive Annual Product Reviews, ensuring alignment with regulatory requirements and promoting continuous improvement in product quality and process efficiency
• Supports reliable production during regular operations
• Leads troubleshooting as a process subject matter expert (SME)
• Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs)
• Identifies and/or drives highly technical improvement projects in Drug Product (DP)
• Collaborates with cross-functional teams (e.g., DSM, MSAT, and Tech Transfer) to recommend and perform updates to documentation, ensuring accuracy and alignment with evolving processes and standards
• Coordinates non-batch activities and creation of associated documentation for changeover and PMs
• Initiates or supports change management records, investigations, CAPAs, and continuous improvement (CI) activities
• Provides support during inspections and audits by assisting in the backroom or acting as a runner, ensuring efficient access to required documents and information, while maintaining organized and transparent audit processes
• Performs other duties, as assigned

Basic Requirements

• High school diploma or GED with 8 years related experience in life sciences manufacturing OR
• Associate’s Degree in Pharmaceutical Sciences, Biotechnology, Microbiology, or a related field with 6 years related experience in life sciences manufacturing OR
• Bachelor’s in Pharmaceutical Sciences, Biotechnology, Microbiology, or a related field with 4 years related experience in life sciences manufacturing OR
• Equivalent military experience or training

Preferred Requirements 

• Experience in drug product manufacturing, sterile processing, or quality assurance
• Strong knowledge of cGMP, FDA, EMA, and MHRA
• Experience developing and delivering technical training programs
• Experience with learning management systems

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• 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 wrists, hands and/or fingers

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.

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).