Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

What will you do?

Our company is seeking a Quality Engineer 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.

How will you make an impact?

• 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 here?

• A Bachelor's Degree is required for this Position.
• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.
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