Validation QA Engineer — Ensuring cGMP System Excellence

Merck & Co.; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities. You will review, approve validation documents, and ensure facilities, utilities, and equipment remain in a validated state throughout changes and decommissioning.

The role demands strong communication, cgmp expertise, and the ability to work in a fast-paced, 24/7 manufacturing environment with occasional travel.

Qualifications

• Bachelor's degree in Life Sciences or Engineering with 5 years of applicable industry experience; OR,
• Master's degree in Life Sciences or Engineering with 3 years of applicable industry experience; OR,
• PhD in Life Sciences or Engineering with 1 year of applicable experience.
• 3+ years of experience working in a GMP regulated environment.
• Experience in Validation and/or Quality oversight, in an FDA regulated facility.

Responsibilities

• Acts as SME within QA for development of validation documents and procedures.
• Assesses impact of system/process changes and maintains validation state.
• Oversight and approval of lifecycle documentation including risk assessments and specs.
• Generates, reviews, and approves QA procedures and validation plans.
• Ensures QA support for manufacturing operations in cgmp facility.
• Meets project timelines and quality objectives.
• Supports 24/7 manufacturing operations when needed.

Skills

Communication

Time management

Critical thinking

Collaboration

cGMP knowledge

Genki culture

Travel

Education

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

3+ years of GMP experience

Tools

Smartsheets

Trackwise

Veeva

Kneat validation software

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities. You will review, approve validation documents, and ensure facilities, utilities, and equipment remain in a validated state throughout changes and decommissioning.

The role demands strong communication, cgmp expertise, and the ability to work in a fast-paced, 24/7 manufacturing environment with occasional travel.