Engineer III, QA

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

Location/Division Specific Information

Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD 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 outstanding 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. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

Discover Impactful Work:

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.

A Day in the Life:

• 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.

Keys to Success:
Education

• Bachelors degree engineering or science fields is required.

Experience

• 4-5 years in Qualification and Validation in pharma, or medical device environment required.
• 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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.