Digital Operations Associate

Merck & Co.; Holly Springs (NC); Hybrid; USD 52,000 - 78,000; Full time

Benefits offered by this job

Competitive compensation

Health coverage

Retirement plan

Paid time off

Training & mentorship

Hybrid work flexibility

Inclusive culture

Meaningful work

Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking an entry to mid-level professional to join the Digital Operations team. This role supports cGMP biomanufacturing by deploying MES and electronic batch systems, performing data collection, and ensuring compliant, reliable digital operations.

The candidate will learn and grow within a collaborative environment, coordinating with Manufacturing, Automation, and Quality to sustain recipe-driven operations and on-call support as needed.

Qualifications

• Foundational MES knowledge and electronic batch documentation ability.
• Understanding of cGMP and data integrity requirements.
• Strong attention to detail and time management.
• Clear written and verbal communication; collaborates well.
• Basic problem-solving with standard techniques.

Responsibilities

• Support deployment and sustainment of digital manufacturing tools per procedures.
• Assist configuration activities for recipe-driven operations.
• Perform data collection, routine analysis, and system monitoring.
• Follow cGMP, data integrity, and compliance standards; escalate issues.
• Contribute to user training and prepare standard-work documentation.
• Coordinate cross-functionally to support digital integration.
• Identify opportunities to streamline tasks and improve work.
• Provide on-call participation as scheduled.
• Maintain accurate records and status updates.

Skills

MES knowledge

Electronic batch documentation

cGMP principles

Data integrity

Attention to detail

Time management

Communication

Problem-solving

Cross-functional collaboration

On-call readiness

Education

Bachelor's degree in Life Sciences, Engineering, Information Systems, or related field

Associate's degree in Life Sciences or Engineering with 2 years related experience

High School Diploma/GED with 4 years related experience

Tools

MES

PI data historian

DCS/PLC

LIMS

ERP integration

Job description

Position Overview

Make a meaningful impact at the intersection of biomanufacturing and digital operations. If you're excited to learn and grow while supporting cGMP production with modern tools like MES, data historians, and electronic logbooks, this role is a great entry point into a high-impact, highly collaborative environment.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

About Us

• We are a cGMP biomanufacturing organization focused on reliable, compliant, and efficient drug substance production.
• Our Digital Operations team partners closely with Manufacturing, Automation, and Quality to deploy and sustain recipe-driven operations and electronic batch execution.
• We value learning, collaboration, and continuous improvement-and we set our teams up for success with clear procedures, supportive leadership, and opportunities to build new skills.

Responsibilities

• Support deployment and sustainment of digital manufacturing tools (e.g., MES, data historians, electronic logbooks) by executing clearly defined tasks within established procedures.
• Assist with configuration activities for recipe-driven operations and prepare documentation for review and approval.
• Perform basic data collection, routine analysis, and system monitoring to help ensure consistent, reliable digital operations.
• Follow cGMP, data integrity, and compliance standards; escalated non-routine issues to senior team members.
• Contribute to user training by preparing materials, documenting standard work, and conducting walkthroughs under supervision.
• Participate in cross-functional coordination to support digital integration and electronic batch execution.
• Identify straightforward opportunities to streamline tasks or standard work and contribute to continuous improvement.
• Provide on-call support participation as scheduled, with guidance from senior staff.
• Maintain accurate records, logs, and status updates for assigned tasks.
• Perform other duties as assigned.

What you'll bring (Minimum Qualifications)

• One of the following:
  • High School Diploma/GED with 4 years of related experience; or
  • Associate's degree in Life Sciences or Engineering with 2 years of related experience; OR
  • Bachelor's degree in Life Sciences, Engineering, Information Systems, or related field; OR
  • Equivalent practical experience with no prior experience
• Foundational knowledge of MES and electronic batch documentation, with the ability to learn digital manufacturing systems quickly.
• Understanding of cGMP principles and data integrity requirements; applies established procedures and standards.
• Strong attention to detail, organization, and time management; delivers accurate, timely work.
• Clear written and verbal communication; collaborates effectively and seeks feedback.
• Basic problem-solving skills and ability to apply standard techniques to routine issues, escalating when appropriate.
• Familiarity with manufacturing processes and cross-functional collaboration.
• Willingness to support a 24/7 manufacturing environment as needed, including rotational on-call.

Preferred Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related discipline.
• Experience (internship/co-op/project) supporting digital manufacturing systems (e.g., MES, PI/data historian, DCS/PLC, LIMS, ERP integration).
• Familiarity with GMP/GLP requirements and biological manufacturing environments.

Benefits

• Competitive compensation with opportunities for growth and skill development.
• Comprehensive health and wellness coverage for you and your family.
• Retirement savings plan with company support.
• Paid time off, holidays, and leave programs.
• Training, mentorship, and learning opportunities to accelerate your development in digital manufacturing.
• Potential hybrid work flexibility depending on role and site needs.
• Inclusive, collaborative culture that values diverse perspectives and ensures equitable opportunities.
• Meaningful work that supports compliant, reliable drug substance manufacturing.

Accessibility and Work Environment

• This role supports a 24/7 manufacturing environment and includes rotational on-call participation.
• Work may include time in mechanical/production areas with standard safety requirements and use of powered industrial trucks.
• Ability to sit for up to 60 minutes at a time, stand for up to 30 minutes at a time, operate machinery, and occasionally move objects up to 33 lbs; ability to discern audible cues and work with corrected vision as needed.
• We are committed to providing reasonable accommodations throughout the application and employment process. If you need assistance, please let us know.

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 ([e-mail]).