Quality Engineer

at  Thermo Fisher Scientific

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.

QUALIFICATIONS

• BS in Scientific/Technical field with a minimum of 5 to 8 years of related experience in the pharmaceutical industry, specifically in commercial manufacturing quality assurance. Knowledge of scientific principles is required. An equivalent combination of education and experience may be substituted.
• Effective time and project management skills.
• Ability to independently balance multiple projects simultaneously.
• Articulate and support TFS strategy, direction, and decisions, ensuring their accurate execution within the Quality organization.
• Demonstrate role model behavior consistent with TFS Values.

LANGUAGE SKILLS

• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, standard operating procedures, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, top management, public groups, boards of directors, customers, and the general public.

OTHER SKILLS AND ABILITIES

• Use sophisticated technical and/or interpersonal problem-solving activities using proven tools such as statistical analysis and Design of Experiments (DOE).

SPECIAL REQUIREMENTS

• Must meet applicable DEA security clearance requirements.

• 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.