Quality Engineer II
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Job Location:
Saint Louis, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 cGMPs 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 ones 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 CAPAs 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.
Education and Experience
- Bachelors Degree (BA/BS) in Life Sciences (biology chemistry biochemistry) or Engineering with a minimum of three (3) years of relevant experience; or a High School diploma with a minimum of five (5) 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
- 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
- Tech transfer experience is a plus
- Experience with Lean Manufacturing and Six Sigma methodologies is a plus
- Excellent problem-solving and analytical skills
Skills
- 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
Abilities
- 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
Physical Requirements / Work Environment
- 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
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Other
Relocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future without sponsorship.
Must be able to pass a comprehensive background check which includes a drug screening.
Required Experience:
IC
Key Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
