Validation Engineer II - Drive GMP Quality in Manufacturing

ThermoFisher Scientific; Tijuana; On-site; MXN 300,000 - 600,000; Full time

Job summary

Join Thermo Fisher Scientific as a Validation Engineer II and contribute to validation across pharmaceutical manufacturing, lab operations, and quality control. You will ensure compliance, quality, and operational excellence through comprehensive validation activities using IQ/OQ/PQ protocols.

In this role, you’ll work with cross-functional teams in GMP-regulated environments, manage validation projects independently, and apply risk assessment and gap analysis to optimize validation plans.

Qualifications

• Advanced degree with no prior experience required, or Bachelor's degree plus 2 years of validation experience in GMP/regulated environment.
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
• Valid driver's license with ability to travel up to 25% as needed
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
• Strong technical writing skills for validation documentation
• Experience with IQ/OQ/PQ protocols and execution
• Proficiency in risk assessment and gap analysis
• Experience managing validation projects independently
• Strong data analysis and problem-solving capabilities
• Clear verbal and written communication skills
• Proficient in Microsoft Office applications
• Knowledge of calibration and metrology principles
• Experience with automation systems and computer system validation
• Ability to work in cleanroom environments when required
• Effective interpersonal skills for team collaboration
• Ability to manage multiple projects
• Experience with quality management systems and documentation
• Knowledge of statistical analysis and process control methods
• Consistent record of completing projects on schedule in a deadline-oriented environment

Responsibilities

• Ensure compliance, quality, and operational excellence across facilities through comprehensive validation activities.
• Perform IQ/OQ/PQ validation activities and documentation.
• Collaborate with cross-functional teams in GMP-regulated settings.
• Manage validation projects independently and on schedule.
• Apply risk assessment and gap analysis to validation plans.

Skills

Data analysis

Technical writing

Project management

Communication

Travel up to 25%

Education

Bachelor's degree + 2 years GMP experience

Advanced degree

Preferred fields: Engineering/Life Sciences/Chemistry

Tools

IQ/OQ/PQ protocols

Microsoft Office

cGMP compliance knowledge

Documentation management

Job description

Join Thermo Fisher Scientific as a Validation Engineer II and contribute to validation across pharmaceutical manufacturing, lab operations, and quality control. You will ensure compliance, quality, and operational excellence through comprehensive validation activities using IQ/OQ/PQ protocols.

In this role, you’ll work with cross-functional teams in GMP-regulated environments, manage validation projects independently, and apply risk assessment and gap analysis to optimize validation plans.