Engineer II, 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 Engineer II, QA Floor position at Thermo Fisher Scientific is a critical role within the Pharma Services Group located in St. Louis, MO. This facility is a fast-paced biologic drug substance manufacturing site that operates continuously and employs around 1,000 people. The primary focus of this facility is on cell process development to support both clinical and commercial manufacturing, producing products that treat chronic health conditions, including cancers and other life-threatening diseases. This non-supervisory role will work closely with the Supervisor of QA Operations and is expected to adhere to a shift schedule that includes weekend work and an on-call rotation from Wednesday to Saturday, 6 AM to 4:30 PM. As a Quality Engineer II, you will be responsible for ensuring the quality of production processes and performance in a highly regulated environment. This role involves evaluating existing production processes and participating in projects aimed at engineering quality improvements. You will be expected to understand contamination and cross-contamination issues, observe aseptic practices, and perform daily GEMBAs (a Japanese term meaning "go and see") in manufacturing areas. Your responsibilities will also include conducting compliance inspections, supporting manufacturing and process engineering with quality input, and initiating deviations as necessary. All activities will be in support of producing and releasing quality bulk drug substances for clinical and commercial clients. In this role, you will spend the majority of your work hours in manufacturing areas, collaborating with multi-functional teams to develop, optimize, and improve 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. You will also be responsible for performing QA approvals, reviewing autoclave logbooks, conducting Fit and Finish inspections, and participating in training and mentorship of new team members. This position requires strong interpersonal skills and the ability to work effectively in a dynamic environment, as you will need to coordinate with various stakeholders without direct authority.

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 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 with guiding procedures, batch records, and established aseptic practices and be available to manufacturing and Process Engineering for support in real time.
• Conduct daily GEMBAs of 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 Manufacturing 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 is essential.
• Experience with investigational writing software system (TrackWise) 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.
• Excellent problem-solving and analytical skills are preferred.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Outstanding career and development prospects
• Innovative and forward-thinking environment
• Culture of integrity, intensity, involvement, and innovation