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101495BR Sr. Validation Specialist US - Oregon - Bend Engineering|Facilities / Real Estate

Thermo Fisher Scientific Bend, OR
  • Posted: August 21, 2019
  • Full-Time
Job ID :
101495BR
Location :
US - Oregon - Bend
:
Job Description
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.

Location/Division Specific Information
Bend, OR; Pharma Services

How will you make an impact?

You will provide site level manufacturing infrastructure support. Carry out business processes including equipment and facility validation, change control, calibration, preventative maintenance and related documentation.

What will you do?
  • Work closely with site level leaders to support operations by authoring documents, maintaining computer databases, and executing various protocols.
  • Coordinate with Quality Assurance to author, and execute change controls, deviation reports, investigations, preventative maintenance work orders, and other equipment related documentation tasks in accordance with departmental Standard Operating Procedures (SOP's).
  • Track and analyze data related to equipment usage, repair history, parts consumption and uses data to prepare operational readiness reports.
  • Perform periodic reviews or re-qualifications to maintain current validation status of equipment, facilities, utilities and systems as defined by approved validation SOPs
How will you get here?
  • Bachelor's Degree required - preferably in Engineering.Combination of education and relevant validation-type experience will be considered.
  • One to two years of relevant experience strongly preferred (including internships).
  • Qualification experience in GMP or similar regulated environment.
  • Experience drafting and executing protocols.
Knowledge, Skills, Abilities
  • Knowledge of Current Good Manufacturing Practices (cGMP) preferred.
  • Knowledge of industry standards such as Good Automation Manufacturing Practices (GAMPs), Medicines & Healthcare products Regulatory Agency (MHRA), and/or Code of Federal Regulations Title 21 (21CFR) preferred.
  • Strong proficiency in all aspects of equipment and systems validation including standalone equipment, integrated systems, facilities and maintenance of the systems preferred.
  • Proficiency in Microsoft Office Suite and Computer Aided Drafting (CAD) software required.
  • Working knowledge of controlled documentation and data systems.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling 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.



If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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

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