1+ months

Quality Specialist Engineer-Validations

Pennsylvania, US
Location :
US - Pennsylvania - Allentown
Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
Clinical Trials Division partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more.

How will you make an impact?

In this key role, you’ll be responsible for quality approval for equipment validations (IQ,OQ,PQ), risk assessments (FMEA), alarm management (temperature, humidity, differential pressure), and oversite of Maximo work order system (calibration, corrective maintenance).This role requires the ability to make decisions that are based on sound quality/compliance principles and appropriate GMP Regulations.

What will you do?

  • Apply Good Manufacturing Principles in all areas of responsibility.
  • Demonstrate and promotes the company vision.
  • Review impact analysis of changes to facilities and equipment.
  • Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
  • Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
  • Drives continuous improvement to the site’s equipment and facilities qualification/validation program.
  • Assist in the review of site procedures related to equipment and facilities as required
  • Monitor the site’s calibration program.
  • Monitor the site’s preventative maintenance program.
  • Facilitate, participate, and approve Risk Assessment.
  • Conduct all activities in a safe and efficient manner.
  • Other duties may be assigned to meet business/compliance needs.

How will you get there?
  • Bachelor's Degree
  • A minimum of 5 years in the pharmaceutical/related regulated industry.
  • Experience with equipment and facilities validation Quality Systems.
  • Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
  • Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.
  • Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.
  • Good written and verbal communication skills.
  • Thorough understanding of regulatory documentation requirements.
  • Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
  • Ability to work independently.
  • Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems.
  • Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
  • Experience in Risk Assessment.

Physical Requirements
  • This position is administrative and is positioned in an office environment but does require some time in manufacturing, packaging, and computer areas.
  • It requires standing bending reaching, walking and talking as well as exerting up to 20lbs.

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.

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.


Posted: 2019-08-02 Expires: 2020-01-05

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Quality Specialist Engineer-Validations

Pennsylvania, US
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