Engineer II, QA at Thermo Fisher Scientific in St. Louis, Missouri

Job Description:

Work Schedule

Second Shift (Afternoons)



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, Office



Job Description





Job Title: Quality Engineer II - QA Floor




Requisition ID:





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 outstanding 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 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. Wednesday- Saturday

, 02:00PM-12:30AM.





Discover Impactful Work:



Quality Engineer II is a quality assurance professional with meaningful 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 GEMBA 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 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


• Individuals in this group must be able to acquire agreement and partnership 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 with internal and external customers is crucial.


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Education and Experience



Bachelor's Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry), Engineering, or a related field, with three (3) years of experience.


Experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred.


Cleanroom manufacturing experience with full ISO 5 and ISO 7 gowning requirements is highly preferred.


Non-science degrees will be considered with a minimum of seven (7) years of directly related work experience in biopharmaceutical manufacturing.



Knowledge



Understanding of Quality practices, cGMP regulations, and international health authority guidelines.


Familiarity with investigational writing software (Track Wise) and root cause analysis tools.


Strong technical writing skills and ability to author/revise procedures in document management software.


Tech transfer experience is a plus.


Knowledge of Lean Manufacturing and Six Sigma methodologies is advantageous.


Excellent problem-solving and analytical skills.



Skills



Analytical, critical thinking, and problem-solving abilities.


Strong interpersonal, written, and oral communication skills.


Attention to detail and strong math skills.


Proficiency in Microsoft Office, especially Word and Excel.


Solid time management and organizational skills.



Abilities



Successfully complete tasks according to given instructions.


Multi-task efficiently in a dynamic environment.


Work effectively under pressure and independently.


Demonstrate leadership and coordinate workloads for junior team members.


Understand departmental and site priorities.


Collaborate with colleagues at all organizational levels.



Physical Requirements / Work Environment



Ability to lift < 50 lbs, walk, sit, and focus on a computer screen for extended periods.


Ability 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!


Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.




Apply today! http://jobs.thermofisher.com



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.




Accessibility/Disability Access



Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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