Quality Engineer II

Work Schedule

Third Shift (Nights)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

About Thermo Fisher Scientific:

Thermo Fisher Scientific Inc. is a global leader in serving science, enabling our customers to make the world healthier, cleaner, and safer. With our mission to enable our customers to make the world a better place, we are dedicated to delivering exceptional products and services to support scientific research and discovery.

Location/Division Specific Information

St. Louis MO / Pharma Services Group

The St. Louis site is a fast-paced biologic drug substance manufacturing facility. It operates around the clock and has employs around 1K people. The facility is focused on cell process development to support clinical and commercial manufacturing. The products produced here treat chronic health conditions, including cancers and other life-threatening diseases.

This is a non-supervisory role, working with the Supervisor of QA Operations at the Thermo Fisher St. Louis site. This position will be expected to work a shift schedule that includes weekend work and on-call rotation.

Discover Impactful Work:

Quality Engineer II is a quality assurance professional with substantial prior experience of working within a Quality, Process Engineering, or Manufacturing organization in a highly regulated industry. This individual specializes in evaluation of production processes and performance in manufacturing and participates in projects to engineer quality improvements of existing production processes as well as the development of new processes to improve quality and efficiency. Other job duties include but are not limited to understanding contamination/cross-contamination, observing aseptic practices, performing daily GEMBAs of manufacturing areas, continuously assessing fit and finish of the facility, and performing compliance inspections within manufacturing areas. This role supports Manufacturing and Process Engineering by providing Quality input as needed, and requesting the initiation of deviations as they are identified. All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

What will you do? (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 devia