Quality Engineer III

Pharmaceutical Product Development (PPD)

St. Louis, Missouri, United States of America

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific InformationWork Location: St. Louis, MO (on-site)

Group: Pharma Services Group

Division: Drug Substance Division

What will you do?

  • Assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc.
  • Coach and drive root cause analysis (RCA)
  • Facilitate cross functional teams to evaluate causal factors.
  • Provide written documented investigations per the site rubric in an appropriate and timely manner.
  • Ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues
  • Work without  direct guidance and minimal oversight to get results, meet timelines, and improve processes.
  • Effectively connect with peers and colleagues regarding the status of investigations and offer recommendations based on investigation outcomes.
  • Provide insights based on technical experience and astute judgment as called upon during investigations and daily interpretation of data and results.
  • Perform work with little to no oversight.
  • Perform technical writing of complicated investigations.
  • Provide oversight for technically complicated investigations.
  • Provide client communications and responses.
  • Drive client communications and responses to closure through concurrences.
  • Provide mentorship to deviation management team members.
  • Lead the team in the absence of management.
  • Assign the daily deviation workload in the absence of management.
  • Attending Tier III for deviation updated when needed.
  • Takes ownership of Tier I problem solving and daily accountability.
  • Acts proactively to ensure streamlined process operations and promote team collaboration.
  • Promotes a respectful and collaborative work environment.

How will you get here?

Education

  • Bachelor’s degree in science required, preferably in a scientific discipline.

Experience

  • 3+ years of experience in direct utilization of problem-solving tools (RCA tools including 5-Whys, TapRooT, Fishbone/6M, Kepnor-Tregoe, Comparative Analysis, etc.) with demonstrated success.
  • 3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.
  • Preferred experience in either upstream or downstream processing.
  • Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools.
  • Minimum of 3 years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results.
  • Demonstrated ability to perform intermediate to advanced levels of MS Office functions (Word, PowerPoint, Excel).
  • Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities

  • Proficiency in technical and/or investigative writing.
  • Excellent verbal and written communication skills.
  • Ability to drive functional, technical, and operational excellence.
  • Ability to evaluate data and make recommendations based on data analysis.
  • Ability to make recommendations based on trends and trend analysis.
  • Ability to work in a fast-paced environment with the capability to prioritize effectively to meet timelines.
  • Facilitation skills for groups including staff level employees.
  • Excellent time management and organizational skills to meet deliverables on tight deadlines

This position has not been approved for relocation assistance.

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.

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Job posted: 2024-02-08