Thermo Fisher Scientific Validation Quality Engineer III in Grand Island, New York
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.
What will you do?
To develop and execute the activities related to the validation of equipment, processes, packaging and/or systems used in the manufacture and testing of cGMP products.
Contributes to the strategy and development of the site validation master plan.
Solves problems in complicated situations using analytical and creative thinking skills.
Evaluate and find mitigation for the potential risks that may be involved in a projected activity or undertaking.
Impacts through delivery of results.
Communicates internally to senior leaders and to diverse audiences.
Completes assignments of diverse scope and complexity.
Provides training and constructive input to team members.
Protocol and report writing
Supports complex, cross-functional quality investigations in a variety of subject matter areas (e.g. electrical, mechanical, chemistry and computer systems/software) to determine root cause and corrective action.
Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements.
Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new product introduction projects or quality improvement projects.
May supervise the activities of lower-level personnel.
How will you get here?
High School Diploma or Equivalent required. Bachelor's degree preferred.
3-5 years' experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products
Advanced knowledge of:Validation in a FDA Regulated Environment
Quality standards (e.g., 21 CFR Part 820, ISO 13485, MDSAP)
Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis)
Computer Systems (e.g. TrackWise, AGILE, E1/SAP)
Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project)
Customer or regulatory audit
Advanced knowledge of 21 CFR Part 11.
Advanced knowledge of computer system validation
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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