Role at a glance
- Salary
- Not Disclosed
- Location
- Tijuana, Mexico
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- Advanced degree with no prior experience required, or Bachelor's degree plus 2 years of validation experience in GMP/regulated environment
- Education
- Advanced degree with no prior experience required, or Bachelor's degree plus 2 years of validation experience in GMP/regulated environment
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Role Summary
The Validation Engineer II performs validation activities to support compliance, quality, and operational standards across facilities. The work spans pharmaceutical manufacturing, laboratory operations, and quality control.
What You'll Do
- Conduct comprehensive validation activities across facilities.
- Support compliance and quality through validation work.
- Help maintain standards in pharmaceutical manufacturing, laboratory operations, and quality control.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Required: an advanced degree with no prior experience, or a bachelor's degree plus 2 years of validation experience in a GMP/regulated environment. Requires knowledge of cGMP, FDA regulations and industry standards including ISO and GAMP5; technical writing; IQ/OQ/PQ protocols; risk assessment and gap analysis; validation project management; data analysis and problem-solving; communication and Microsoft Office skills; calibration and metrology knowledge; automation systems and computer system validation experience; cleanroom capability; quality management systems and documentation experience; statistical analysis and process control knowledge; a valid driver's license and ability to travel up to 25%.
Required
- Advanced degree with no prior experience required, or Bachelor's degree plus 2 years of validation experience in GMP/regulated environment
- 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
Preferred
- Engineering
- Life Sciences
- Chemistry
- Related technical field
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowedJob 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
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.