Thermo Fisher Scientific · 1 day ago
Engineer II, QA
St Louis, MO
Full-time
Onsite
Mid Level
3+ years expThermo Fisher Scientific is a leading company in biologic drug substance manufacturing, focused on improving health outcomes for patients. The Quality Engineer II will work in a non-supervisory role to ensure compliance with quality standards in manufacturing processes and collaborate with cross-functional teams to enhance efficiency and quality.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Spend the majority of work hours in manufacturing areas supporting active processing and working closely with Manufacturing and Process Engineering to oversee activities from a quality perspective and provide QA-related input
Collaborate with cross-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality
Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations in preparation for internal quality audits, client audits, and regulatory inspections
Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination
Participate in client and regulatory audits as a SME on the Fit and Finish, Changeover, and Change Control procedures and practices
Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time
GEMBA all active areas daily as well as other areas within the core as scheduled, and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirements
Perform QA approval of suite and equipment changeover between client processes
Perform autoclave logbook review and facilitate corrections
Perform Fit and Finish inspections per the risk assessment and guiding procedures
Perform monthly aseptic observations of critical activities performed in Biosafety Cabinets
Attend and actively participate in MFG huddles
Lead/attend and actively participate in QA OTF Tier 1 huddles
Act as Quality Management Representative for the company as needed
Take actions to develop one’s own knowledge and skills
Perform all training requirements in a timely manner
Provide training, coaching, and mentorship to new and/or less experienced team members on quality standards and effective strategies
Qualify new team members to perform tasks that require QSME training
Write and review deviations in Trackwise as required
Author, revise, and review procedures in eDMS as required
Write and implement CAPA’s as needed
Conduct/participate in investigation interviews/RAPIDs as required
Individuals in this group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential
Qualification
Required
Bachelor's Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry), Engineering, or another science related field combined with a minimum of three (3) years of relevant experience is required
Understanding ‘why' and not just the ‘how' of processes and practices
Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
Experience with investigational writing software system (Track Wise) along with root cause analysis tools utilized in deviation investigations
Technical writing skills and the ability to write/revise procedures in document management software
Analytical, critical thinking, and problem solving skills
Strong interpersonal skills
Strong written and oral communication skills
Strong math skills
Strong attention to detail
Strong Microsoft Office skills (especially Word and Excel)
Solid time management and organization skills
Understand and carry out instructions
Effectively multi-task
Work effectively in a dynamic environment
Able to work under pressure
Able to work independently
Demonstrated ability to lead others
Able to coordinate workload for junior team members
Able to understand departmental as well as site priorities
Ability to collaborate with colleagues at all levels of organization
Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods.- Able to gown, wear PPE, and work successfully in a clean room environment
Preferred
Experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
Cleanroom manufacturing experience is highly preferred along with a comfort level with full ISO 5 and ISO 7 gowning requirements
Non-science degrees will be considered if combined with a minimum of seven (7) years of directly related work experience in biopharmaceutical manufacturing
Tech transfer experience is a plus
Experience with Lean Manufacturing and Six Sigma methodologies is a plus
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
Genetic Engineering News
2026-01-16
Investor's Business Daily
2026-01-16
Company data provided by crunchbase