Validation Engineer I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Description:

Join us as a Validation Engineer I at Thermo Fisher Scientific, where you'll contribute to ensuring product quality and regulatory compliance. You'll be responsible for planning, executing, and documenting validation activities across equipment, processes, and computer systems. Working with cross-functional teams, you'll help maintain our high standards of quality while supporting continuous improvement initiatives. This role offers excellent opportunities for professional growth within an established leader in serving science.

Requirements:

• Responsible for performing validation activities, including Validation Master Plan
• Responsible for continuous improvement within validation
• Responsible for EH&S in validation activities
• Responsible for managing contractors
• Strong knowledge of validation principles including IQ/OQ/PQ protocols and FDA/EMA regulatory requirements
• Strong documentation skills and attention to detail
• Ability to work independently and as part of cross-functional teams
• Excellent written and verbal communication skills in English
• Strong problem-solving abilities and analytical mindset
• Experience with risk assessment methodologies
• Knowledge of data integrity requirements and 21 CFR Part 11 compliance
• Ability to manage multiple priorities effectively
• Experience with equipment qualification, process validation, and cleaning validation
• Act according to Thermo Fisher Scientific Corporate and Thermo Fisher Scientific guidelines, systems and requirements
• Preferred Fields of Study: Engineering, Chemistry, Biotechnology, Biology, or related scientific field

Thermo Fisher Scientific does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected status.