Thermo Fisher Scientific · 4 days ago
Engineer III, QA
Allentown, PA
Full-time
Onsite
Mid Level
4+ years expThermo Fisher Scientific is a global leader in serving science, dedicated to making the world healthier, cleaner, and safer. The Quality Engineer will be responsible for quality approval for equipment validations and risk assessments, ensuring compliance with GMP regulations, and driving continuous improvement in qualification and validation programs.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
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
Qualification
Required
Bachelors degree engineering or science fields is required
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!
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
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
EIN Presswire
2026-01-07
EIN Presswire
2026-01-05
Company data provided by crunchbase