Engineer II, Validation - AVI

Thermo Fisher Scientific • Greenville, NC

5d • Onsite

About The Position

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

Requirements

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

Responsibilities

• Writing validation protocols
• Data analysis
• Reporting
• Documentation
• Executing validation activities alongside team members
• 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 This Job Offers

• Job Type: Full-time
• Career Level: Entry Level