Engineer II, Validation

ThermoFisher Scientific; Greenville (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Join Thermo Fisher Scientific as a Validation Engineer II to drive compliance and quality across our pharmaceutical manufacturing and laboratory operations. You will oversee validation strategies and ensure alignment with cGMP, FDA regulations, and industry standards while collaborating with diverse teams to deliver robust validation programs.

The role focuses on executing IQ/OQ/PQ validation, managing projects independently, and maintaining rigorous documentation in a fast-paced, global

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field (Advanced degree preferred).
• 2 years of validation experience in GMP/regulated environment preferred but not required.
• Experience with IQ/OQ/PQ protocols and execution.
• Experience managing validation projects independently.
• Experience with automation systems and computer system validation.
• Experience with quality management systems and documentation.

Responsibilities

• Ensure compliance, quality, and operational excellence across facilities through validation activities.
• Collaborate with cross-functional teams to execute validation plans and SOPs.
• Maintain thorough validation documentation and traceability across projects.

Skills

cGMP knowledge

FDA regulations

Technical writing

Risk assessment

Data analysis

Clear communication

MS Office

Calibration/metrology

Cleanroom experience

Project management

Statistical analysis

Education

Bachelor's degree in Engineering/Life Sciences/Chemistry

Advanced degree preferred

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, 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 our collaborative team as a Validation Engineer II at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. In this role, you'll be responsible for ensuring compliance, quality, and operational excellence across our facilities through comprehensive validation activities. Working with advanced technologies and diverse teams, you'll help maintain high standards in pharmaceutical manufacturing, laboratory operations, and quality control.

REQUIREMENTS:

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field. Advanced degree preferred
• 2 years of validation experience in a GMP/regulated environment preferred but not required.
• Experience with IQ/OQ/PQ protocols and execution
• Experience managing validation projects independently
• Experience with automation systems and computer system validation
• Experience with quality management systems and documentation

Knowledge, Skills, Abilities:

• Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
• Strong technical writing skills for validation documentation
• Proficiency in risk assessment and gap analysis
• Strong data analysis and problem-solving capabilities
• Clear verbal and written communication skillsProficient in Microsoft Office applications
• Knowledge of calibration and metrology principles
• Ability to work in cleanroom environments when required
• Effective interpersonal skills for team collaboration
• Ability to manage multiple projects
• Knowledge of statistical analysis and process control methods
• Consistent record of completing projects on schedule in a deadline-oriented environment

Note: We are not able to provide relocation assistance or visa sponsorship for this role.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.