Engineer II, QA - QA Floor

Thermo Fisher Scientific - St. Louis, MO

Full-time - Mid Level

St. 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 is designed for a quality assurance professional with substantial experience in a highly regulated industry, particularly in biologic drug substance manufacturing. The St. Louis facility operates continuously, employing around 1,000 people, and focuses on cell process development to support both clinical and commercial manufacturing. The products produced at this site are essential for treating chronic health conditions, including cancers and other life-threatening diseases. As a Quality Engineer II, you will work closely with the Supervisor of QA Operations and will be expected to adhere to a third shift schedule, which includes weekend work and an on-call rotation. The shift runs from 10 PM Saturday night to 8:30 AM Wednesday morning. Your primary responsibilities will involve evaluating production processes, ensuring compliance with Good Manufacturing Practices (GMP), and participating in projects aimed at improving quality and efficiency in manufacturing processes. You will be actively involved in observing aseptic practices, conducting audits, and providing quality input to manufacturing and process engineering teams. In this role, you will spend the majority of your time in manufacturing areas, supporting active processing and collaborating with multi-functional teams to enhance efficiency and quality. You will conduct thorough audits and inspections to ensure compliance with industry standards, participate in client and regulatory audits, and provide immediate coaching to colleagues to prevent contamination. Additionally, you will be responsible for performing QA approvals, conducting aseptic observations, and providing training and mentorship to new team members. Your ability to communicate effectively and utilize tact and diplomacy will be essential in maintaining a quality culture throughout operations.

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.
• 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.

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.
• Experience with investigational writing software system (Track Wise) along with root cause analysis tools used in deviation investigations.
• Technical writing skills and the ability to write/revise procedures in document management software.
• Excellent problem-solving and analytical skills.

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.