Engineer 2, Validation

Merck & Co.; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina, seeks a CQV Engineer 2 to support commissioning and qualification of equipment and systems. You will coordinate validation activities, build dashboards, and ensure compliance with regulatory and quality standards.

The role involves drafting validation protocols, executing validation activities across manufacturing, labs, and process support equipment, and preparing SOP-ready report packages.

Qualifications

• Bachelor's degree in Engineering with 2 years of validation experience in facilities, commissioning, and systems qualifications.
• Experience with cGMP or working in another highly regulated industry preferred.
• Experience with mammalian cell culture process preferred.

Responsibilities

• Configures, tests, and validates electronic systems to ensure proper qualification and validation per standards and FDA requirements.
• Reads P&IDs to walkthrough systems in the field.
• Drafts and implements validation protocols.
• Coordinates execution of validation activities (equipment set up, material readiness, work orders).
• Creates work orders, generates calibration reports, maintenance plans in CMMS.
• Executes validation protocols for manufacturing, lab, process support equipment.
• Develops Tableau dashboards to visualize CQV data and track progress.
• Identifies risks and escalates to senior engineers or management.
• Prepares validation master plans for facilities, equipment, and systems.

Education

Bachelor's degree in Engineering

Tools

Tableau

Job description

Position Overview

The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.

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

• Configures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))
• Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field
• Drafts and implements validation protocols
• Coordinates the execution of validation activities (e.g., equipment set up, material readiness, and work orders)
• Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)
• Executes validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.
• Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trends
• Identifies potential risks and escalates to senior engineers or management for resolution
• Creates, implements, and maintains equipment and system qualifications and validation protocols
• Prepares and presents report packages for implementation into standard operating procedure (SOPs)
• Prepares validation master plans for facilities, equipment, and systems
• Other duties, as assigned

Minimum Qualifications

• Bachelor's degree in Engineering with 2 years of experience in validation activities in facilities, commissioning, and systems qualifications

Preferred Qualifications

• Master's degree in Engineering with no prior experience
• Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
• Prior experience with mammalian cell culture process

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]).