CQV Validation Engineer II - Equipment & Dashboards

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

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.