Engineer II, QA - QA Floor

Thermo Fisher Scientific - Saint Louis, MO

Full-time - Mid Level

Saint Louis, MO

501-1,000 employees

Computer and Electronic Product Manufacturing

About the position

The Quality Engineer II - QA Floor position at Thermo Fisher Scientific is a critical role within the Pharma Services Group located in St. Louis, MO. This position operates on a third shift schedule, specifically from 10 PM Saturday night to 8:30 AM Wednesday morning, and includes weekend work and on-call rotation. The St. Louis site is a biologic drug substance manufacturing facility that operates continuously and employs around 1,000 people. The facility is dedicated to cell process development, supporting both clinical and commercial manufacturing of products that treat chronic health conditions, including cancers and other life-threatening diseases. As a Quality Engineer II, you will be responsible for ensuring that production processes meet the highest quality standards in a highly regulated environment. This role requires substantial prior experience in Quality, Process Engineering, or Manufacturing, particularly within the pharmaceutical or biopharmaceutical sectors. You will specialize in evaluating production processes and performance, participating in projects aimed at engineering quality improvements, and developing new processes to enhance quality and efficiency. Your duties will include understanding contamination and cross-contamination, observing aseptic practices, conducting daily GEMBAs of manufacturing areas, and performing compliance inspections. In this non-supervisory role, you will work closely with the Supervisor of QA Operations and collaborate with multi-functional teams to optimize processes. You will conduct thorough audits and inspections to ensure compliance with industry standards and regulations, participate in client and regulatory audits, and provide immediate coaching to colleagues to prevent contamination. Additionally, you will be responsible for writing and reviewing deviations, authoring and revising procedures, and conducting investigations as needed. This position requires strong analytical and problem-solving skills, as well as the ability to work effectively in a dynamic environment and under pressure.

Responsibilities

• Spend the majority of work hours in manufacturing areas supporting active processing and working closely with Manufacturing and Process Engineering to supervise activities from a quality perspective and provide QA-related input.
• Collaborate with multi-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 Subject Matter Expert (SME) on the Fit and Finish, Changeover, and Change Control procedures and practices.
• Observe critical process steps assuring alignment to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time.
• Conduct daily GEMBA walks in all active areas 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.
• Conduct monthly aseptic observations of critical activities performed in Biosafety Cabinets.
• Attend and actively participate in MFG huddles and 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 and 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.

Requirements

• 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.
• 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.
• Knowledge of Quality practices and cGMP regulations and other international health authority guidelines is essential.
• Experience with investigational writing software system (Track Wise) along with root cause analysis tools used in deviation investigations is required.
• Technical writing skills and the ability to write/revise procedures in document management software are necessary.
• Experience with Lean Manufacturing and Six Sigma methodologies is a plus.

Nice-to-haves

• 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
• Range of employee benefits
• Outstanding career and development prospects
• Innovative and forward-thinking organization
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.