Engineer II, Validation - AVI

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 Aseptic/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