This job has expired

Quality Assurance Engineer - Validation, PM, Calibration

Employer
Thermo Fisher Scientific
Location
Eugene, OR
Closing date
Jun 26, 2022
You need to sign in or create an account to save a job.
Job Title: Quality Assurance Engineer Validation, Preventive Maintenance, Calibration

Requisition number: 195093BR

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 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 100,000 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, Patheon and PPD.

Job Title: Quality Assurance Engineer, Quality Assurance Engineer Validation, Preventive Maintenance, Calibration

Requisition number: 195093BR

Location/Division Specific Information

This position is located at our Eugene, OR facility.

How will you make an impact?

The Quality Engineer (QE) is responsible for management and oversight of all validation and preventive maintenance and calibration activities to support site activities. The QE will be involved in preparing and implementing Installation/Operation/Performance qualification (IQ/OQ/PQ) plans, protocols and reports, and supporting on-time preventive maintenance and calibration. For all projects worked on, active participation and leadership is expected in the origination of design specifications, design for quality and manufacturing requirements, project planning, and applicable documentation. The QE develops, modifies, applies and maintains quality standards, and generates protocols and reports. The QE mentors and coaches Manufacturing, R&D and support personnel on Quality System Requirements and process improvement methods for the sites products and processes.

What will you do?
  • Direct and improve validation activities for the facility, including maintenance of the Validation Master Plan
  • Develop validation plans and protocols, ensuring compliance with site procedures and ISO guidelines
  • Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with Quality System and regulatory requirements
  • Actively partner with Manufacturing and supporting departments on special projects to create and revise qualification and validation protocols, studies, or other improvement projects
  • Facilitate supplier visits related to validation, calibration, preventive and corrective maintenance
  • Support the Facilities department to capture Quality related and validation activities
  • Participate in and support change control activities for documents and manufacturing processes
  • Oversee the execution of the sites preventive maintenance and calibration program, ensuring that OOTs are promptly resolved and risk assessments performed
  • Investigate, analyze and correct process non-conformances (internal, external and systemic issues)
  • Actively seek, build and implement projects for quality improvement
  • Collect, analyze, and present Quality data
  • Define, drive, and implement process and product improvement plans and ensure their effectiveness
  • Participate as internal auditor, and participate in external audits
  • Other duties may be assigned, as required
  • Travel requirement: 0-10%

How will you get here?
  • BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or BS with other equivalent work experience in the Quality Systems area pertaining to a scientific industry
  • 2-5 years experience in the Quality Assurance field required
  • Strong digital literacy (MS Word, MS Excel, MS PowerPoint)
  • Knowledge of Quality Assurance and/or Quality Systems, including standards such as ISO 13485 Medical Devices Quality Management System and ISO 9001 Quality Management Systems

Knowledge, Skills, Abilities
  • Knowledge of Operations processes and familiarity with a manufacturing environment
  • Familiar with enterprise software systems for document control, CAPA management, TrackWise, and learning management systems
  • Knowledge of methods and toolssoftware packages for statistical data analysis (e.g. JMP, Minitab)
  • Able to motivate and positively influence peers
  • Has a proactive and process-driven approach to problem solving
  • Able to define problems, collect data, establish facts, and draw valid conclusions
  • Able to resolve rapidly common or complex inquiries or complaints from internal and/or external customers and regulatory agencies
  • Able to effectively present information to groups of employees, site leadership, and customers
  • Able to read, analyze, and interpret common scientific data and QMS standards

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.

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.
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert