Engineer II, Validation - AVI

Thermo Fisher Scientific•Greenville, NC

6d•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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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
Strong communication and teamwork skills

Nice To Haves

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

Responsibilities

writing validation protocols
data analysis
reporting
documentation
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