What are the responsibilities and job description for the Quality Engineer position at Thermo Fisher Scientific?
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Join Thermo Fisher Scientific Inc. and become a crucial part of a hard-working team dedicated to making the world healthier, cleaner, and safer. As a Quality Engineer, you will play a meaningful role in ensuring our manufacturing processes are flawless and our products meet world-class standards. This is an opportunity to apply your expertise and contribute to our mission of accelerating scientific research and innovation.
Essential Duties and Responsibilities
- Use your understanding of regulatory compliance and quality principles in pharmaceutical operations, specifically in softgel manufacturing, validation, and engineering.
- Work on sophisticated problems requiring in-depth analysis of various factors.
- Lead multi-functional teams engaged in improvement activities.
- Facilitate the increased quality / compliance knowledge of assigned areas.
- Serve as the primary resource and technical authority in areas of problem solving, process / method improvement, and ensuring quality and compliance.
- Direct technical and / or organizational problem-solving activities using proven tools such as statistical analysis and Design of Experiments.
- Identify negative trends in quality / compliance and ensure correction of root causes of deficiencies.
- Review and approve procedures, design plans, manufacturing processes, qualification and / or validation protocols, investigational test plans, investigation reports, change control requests, and other operational documentation where QA review and approval are required.
- Drive the implementation and improvement of policies and procedures consistent with regulatory policies, customer expectations, and fundamental principles of quality.
- Assure the identification and implementation of sophisticated quality and compliance management principles resulting in positive changes in operations.
- Operate with minimal direct supervision and assume a leadership role in leading projects.
- Develop technical and interpersonal recommendations with significant impact and use influence to drive ongoing improvement of quality and compliance.
- Other duties as assigned.
Qualifications
Language Skills
Other Skills and Abilities
Special Requirements
Physical Demands
