Quality Engineer (Validation - Capacity Expansion)

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Key Responsibilities: Manage site quality projects with site cross functional teams

• Facilitate implementation of project deliverables (processes, equipment, behaviors)
• Draft technical documents (IQ/OQ/PQ)
• Facilitate continuous improvement
• Collect, analyze and present quality data.
• Develop, write, edit and approve protocols and procedures

Minimum Qualifications:

• Bachelor's degree in engineering or science related field.
• 3+ years of quality or engineering experience.
• Proven track record of problem solving and root cause analysis
• Ability to travel; domestic / foreign
• Experience interacting with customers

Preferred Qualifications:

• Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
• Strong working knowledge of Sterilization of health care products - Radiation (ISO 11137 and/or ISO 13004)
• Strong working knowledge of Cleanroom and associated controlled environments (ISO14644)
• Ability to understand various manufacturing processes.
• Excellent writing and communication skills.
• Technical writing
• Ability to interface well with others at all working levels.
• Ability to perform investigative process as well as critical thinking and problem solving.
• Working to advanced knowledge of Microsoft Office suite.
• Ability to read and understand CAD drawings.
• Ability to manage multiple projects simultaneously
• Positive attitude and solid communication skills
• Ability to prioritize and manage project work
• Proficient in Microsoft Applications; Word, Excel, Project, and PowerPoint
• Ability to work with many different types of personalities
• Ability to work alone or in team environment

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.