Engineer II, Validation - AVI

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Discover Impactful Work:

As part of the Thermo Fisher Scientific team, you’ll do meaningful work that makes a positive impact on a global scale. Join colleagues who bring our Mission to life every day—enabling customers to make the world healthier, cleaner, and safer.

Join our growing validation team supporting Automatic Visual Inspection (AVI) operations, a critical and expanding function within sterile pharmaceutical manufacturing. With new lines being added—including auto-injector technology—this role offers hands-on experience in one of the most in-demand areas of the industry.

This is an entry-level opportunity designed for growth, where you’ll gain valuable, highly marketable experience in sterile manufacturing validation.

A Day in the Life:

This role offers a balance of technical documentation and hands-on execution:

• ~60% desk-based: writing validation protocols, data analysis, reporting, and documentation
• ~40% on the production floor: executing validation activities alongside team members
• Partner with experienced engineers for hands-on training and execution
• Participate in data calculations, evaluations, and summary reports
• Gradually interface with clients and become a point of contact
• Work directly with commercial manufacturing equipment in sterile/inspection environments

What to Expect:

• Structured onboarding with SOP training and hands-on mentorship
• Direct exposure to AVI and sterile pharmaceutical processes
• Career growth within a rapidly expanding function (AVI + auto-injector lines)
• Collaborative team environment (team of ~4 engineers)

Keys to Success:

Education & Experience:

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related field
• 0–2+ years of experience in validation or regulated/GMP environment preferred

Required Skills & Experience:

• Strong technical writing and documentation skills
• High attention to detail and quality-focused mindset
• Comfort working around large-scale manufacturing equipment
• Ability to learn quickly in a hands-on environment
• Exposure to pharmaceutical manufacturing—especially sterile/aseptic environments—is strongly preferred and highly valued

Additional Requirements:

• Knowledge of cGMP and regulated environments preferred
• Familiarity with IQ/OQ/PQ concepts a plus
• Ability to work onsite in Greenville, NC (Monday–Friday, standard hours)
• Strong communication and teamwork skills

Why Join Us:

• Entry point into high-demand sterile validation engineering
• Hands-on learning with experienced mentors
• Exposure to cutting-edge pharmaceutical technologies (AVI & auto-injectors)
• Clear career progression into advanced validation roles