Engineer III, Validation

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Location/Division Specific Information

This role is based at our sites in Fairlawn and Bridgewater, NJ, supporting our Laboratory Chemicals Division. These sites maintain ISO 9001 Quality Management System (QMS) certifications, manufacturing reagents and chemicals used for a breadth of applications from life sciences research to drug discovery and manufacturing.

How you will make an impact:

We are seeking a highly skilled and motivated Validation Engineer to join our dynamic team. The Validation Engineer will be responsible for ensuring that our systems, processes, and products meet all vital regulatory standards and specifications. This role involves extensive testing, documentation, and analysis to validate the performance and compliance of our solutions.

What will you do:

• Develop and implement validation protocols and test plans for systems, processes, and products.
• Conduct validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform risk assessments and identify critical control points within systems and processes.
• Prepare and maintain detailed validation documentation, including validation plans, reports, and traceability matrices.
• Collaborate with multi-functional teams such as Quality Assurance, Regulatory Affairs, and Engineering to ensure compliance with industry standards and regulations.
• Analyze test data and results to identify trends, deviations, and areas for improvement.
• Ensure that all validation activities are completed on time and within budget.
• Offer training and support to team members regarding validation procedures and standard methodologies.
• Stay updated with the latest industry standards, guidelines, and regulatory requirements related to validation.

How will you get here:

• Bachelor's degree in Engineering, Science, or related field.
• Minimum 2 years experience in validation engineering or a related role.
• Strong understanding of validation principles, practices, and methodologies.
• Knowledge of regulatory requirements such as FDA, EMA, and ISO standards.
• Excellent analytical, problem-solving, and organizational skills.
• Proficient in technical writing and documentation.
• Ability to work independently and as part of a team.
• Strong communication skills and attention to detail.

Preferred Qualifications:

• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Certification in validation or related field.
• Familiarity with computer system validation (CSV).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!