Engineer II, Validation
Thermo Fisher Scientific
Validation Engineer II at Thermo Fisher Scientific ensures compliance and quality in pharmaceutical manufacturing and laboratory operations through comprehensive validation activities in GMP-regulated environments. The role involves managing validation projects, executing protocols, and maintaining high standards across facility operations.
Responsibilities
- Execute comprehensive validation activities including IQ/OQ/PQ protocols in GMP environments
- Manage validation projects independently while ensuring regulatory compliance and quality standards
- Develop technical validation documentation and conduct risk assessments and gap analyses
- Collaborate with cross-functional teams on automation systems and computer system validation
- Perform data analysis and problem-solving to support facility operational excellence
Requirements
- Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field
- 2+ years validation experience in GMP/regulated environment preferred
- Experience with IQ/OQ/PQ protocols and independent project management
- Knowledge of cGMP, FDA regulations, ISO standards, and GAMP5 framework
- Strong technical writing skills and proficiency in risk assessment and gap analysis
- Proficiency with Microsoft Office and cleanroom environment familiarity
Vacancy posted 11 days ago
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