Deviation Investigator

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility and is growing. We are looking for professionals to grow with us and we have this exciting opportunity for a Deviation Investigator. The Deviation investigator is responsible for the initiation, investigation of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence.

The Investigator is seen as an investigational technical expert. The Investigator is expected to work in a cGMP environment, have the ability to manage multiple ongoing projects concurrently as well as mentor and train others within the group, have excellent meeting facilitation and conflict resolution skills, a professional and expert technical writing capability, be action oriented, and be compliant minded while performing investigations. This is a cross-functional position that interacts with Quality Systems, Manufacturing, Materials Management, Maintenance and QC-Microbiology. This position generates investigations, works with all departments within the facility and may include data compilation and evaluation, impact assessments, root cause analyses, and corrective/preventive actions. The Deviation Investigator also has responsibilities in the data entry, generation and evaluation of process and performance metrics.

Key Responsibilities:

  • Ensure event and deviation timelines are maintained through inter-department communication
  • Able to handle more challenging, in-depth investigations utilizing more advanced investigational tools while still maintaining the high level of quality
  • Helps drive changes in processes/procedures.  Able to assist the manufacturing team in submitting change controls, investigations, CAPAS, etc.
  • Periodically summarize and present on-going process and performance metrics
  • Gown and enter aseptic manufacturing to support investigations
  • Member of the Asset Leadership team and must represent the Asset in a professional manner at all times
  • Learns from experience, errors and setbacks . Helps others learn from experience to develop themselves
  • Uses knowledge of his/her business area and related areas to make correct and timely decisions
  • Works in partnership as an active member of his/her team and cross- functional working groups
  • Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement
  • Helps peers (and team) overcome performance obstacles and challenges
  • Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)
  • Takes personal accountability for outcomes resulting from choices and behaviors of self and team

Key Requirements:

  • BA/BS in Biochemistry, Chemical Engineering, Biology or other relevant science discipline
  • Advanced experience with investigations
  • Bio/Pharma industry experience preferred
  • Prior experience working in a manufacturing environment and troubleshooting manufacturing related issues
  • Root cause analysis and technical writing experience required

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R39104
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