Quality Engineer

at  Thermo Fisher Scientific

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.

A DAY IN THE LIFE:

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.

• 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 GMP documents to ensure compliance with all applicable internal and regulatory standards.
• Advises 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.
• Ensure Compliance to the site calibration program.
• Supervise the 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.

EDUCATION

• Bachelors degree engineering or science fields

EXPERIENCE

• 4+ years in Qualification and Validation in pharma environment.
• A minimum of 2 years in the pharmaceutical/related regulated industry.
• Experience with process validation in Quality Systems.
• Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems.
• Experience in Risk Assessment!

KNOWLEDGE, SKILLS, ABILITIES

• Must be detail oriented to detect errors or deficiencies in validation and qualification documentation and requirements of the system
• Utmost integrity and personal responsibility are required to maintain the for regulatory compliance.
• Good written and verbal and communication skills.
• Detailed 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.
• Proficiency in skills required to read, understand, and enforce to the SOPs and policies of a GMP environment.

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.

• 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 GMP documents to ensure compliance with all applicable internal and regulatory standards.
• Advises 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.
• Ensure Compliance to the site calibration program.
• Supervise the 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