Manufacturing Engineer II

ThermoFisher Scientific; Tijuana; Sur place; MXN 300 000 - 600 000; Plein temps

Résumé du poste

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

Responsabilités

• 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.

Connaissances

Data analysis

Technical writing

Project management

Communication

Travel up to 25%

Formation

Bachelor's degree + 2 years GMP experience

Advanced degree

Preferred fields: Engineering/Life Sciences/Chemistry

Outils

IQ/OQ/PQ protocols

Microsoft Office

cGMP compliance knowledge

Documentation management

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed

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

• 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

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.