Engineer II, Validation
About the role
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
Qualifications
- 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 skills
- Proficient 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
Schedule
Standard (Mon-Fri)
Work environment
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.)
Note: We are not able to provide relocation assistance or visa sponsorship for this role.