Jr Validation Engineer
Para Monterrey, Nuevo León,
Junior Validation Engineer – Plastic Injection Molding
Location: Monterrey, Nuevo León, Mexico
Position Summary
Thermo Fisher Scientific is seeking a Junior Validation Engineer – Plastic Injection Molding for our Monterrey, Nuevo León location. This role is responsible for supporting and executing validation activities for plastic injection molding processes, ensuring compliance with applicable quality standards, regulatory requirements, and internal procedures.
The ideal candidate will have experience in process validation, equipment qualification, cleaning validation, and plastic injection molding, preferably within the medical device, pharmaceutical, or healthcare manufacturing industry.
Qualifications
- Bachelor's degree in Plastics Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
- Minimum of 3 years of experience in plastic injection molding process validation.
- Experience with equipment qualification, process validation, and cleaning validation.
- Knowledge of IQ/OQ/PQ and PPQ methodologies.
- Knowledge of ISO 13485, FDA QSR (21 CFR 820), ISO 14971, ISO 10993, and GMP requirements.
- Experience with Statistical Process Control (SPC) and process capability analysis (Cp, Cpk).
- Experience preparing validation plans, protocols, reports, and risk assessments.
- Knowledge of plastic materials, injection molding processes, and material properties.
- Experience with Minitab is preferred.
- Intermediate to advanced English proficiency (reading, writing, and conversational).
Key Competencies
- Analytical thinking and problem-solving.
- Strong attention to detail and quality.
- Effective communication and teamwork.
- Organization and priority management.
- Results-oriented mindset.
- Integrity and ethics.
- Adaptability and continuous learning.
- Strong commitment to compliance and continuous improvement.
What We Offer
- Collaborative and inclusive work environment.
- Professional development and career growth opportunities.
- Competitive benefits.
- The opportunity to contribute to Thermo Fisher Scientific's mission of enabling our customers to make the world healthier, cleaner, and safer.