Quality Engineer

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

• 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.

Physical Demands

• No lifting or special vision requirements.