Staff Process Engineer - Upstream at Thermo Fisher Scientific

Posted in Other about 3 hours ago.

Location: St. Louis, Missouri





Job Description:

Work Schedule

Other



Environmental Conditions

Office



Job Description




About Us: Patheon, Thermo Fisher Scientific Inc. is a leading innovator in CDMO Biologics Manufacturing. We are committed to delivering high-quality products and services that meet the evolving needs of our customers. Our team is composed of talented professionals who are dedicated to excellence and continuous improvement.



Position Summary: We are seeking a highly skilled and experienced Staff Process Engineer with a strong background in Upstream, Downstream and Chemistry, Manufacturing, and Controls (CMC). The successful candidate will play a critical role in optimizing and improving our manufacturing processes, ensuring compliance with industry standards, and driving continuous improvement initiatives.



Key Responsibilities:




Process Development and Optimization:



  • Optimize and drive implementation manufacturing processes to enhance efficiency, quality, and cost-effectiveness.

  • Conduct process simulations, modeling, and scale-up activities to support production requirements.


CMC Expertise:



  • Provide technical leadership and expertise in CMC activities, including process development, validation, and regulatory documentation.

  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.


Continuous Improvement:



  • Identify opportunities for process improvements and lead initiatives to enhance productivity, reduce waste, and improve product quality.


Technical Support:



  • Provide technical support to upstream and downstream manufacturing operations, troubleshooting process issues, and implementing corrective actions.

  • Provide technical support during manufacturing deviation investigations.

  • Provide technical support to internal site projects and initiatives.


Project Management:



  • Lifecycle management for commercial programs.

  • Coordinate with internal and external stakeholders to achieve program objectives and timelines.


Training and Mentorship:



  • Mentor and train junior engineers and production staff on best practices, process optimization techniques, and CMC principles.

  • Foster a culture of continuous learning and improvement within the team.


Qualifications:




  • Education and Experience:

  • Bachelor's degree in Chemical Engineering, Biomedical Engineering, biochemistry or a related field plus 8 years of biotechnology or pharmaceutical industry experience.

  • Master's degree in Chemical Engineering, Biomedical Engineering, biochemistry or a related field plus 5 years of biotechnology or pharmaceutical industry experience.

  • Ph. D in Chemical Engineering, Biomedical Engineering, biochemistry or a related field plus 3 years of biotechnology or pharmaceutical industry experience.

  • Proven experience in CMC activities, including process development, validation, and regulatory compliance.


Skills:



  • Strong analytical and problem-solving skills.

  • Proficiency in process simulation and statistical modeling software.

  • Knowledge of Lean Six Sigma methodologies and tools.

  • Excellent communication and interpersonal skills.

  • Ability to work effectively in a team-oriented and fast-paced environment.


Work Environment:



  • This position may require occasional travel to manufacturing sites and other company locations.

  • Ability to gown in a GMP manufacturing environment


What We Offer:



  • Competitive salary and benefits package.

  • Opportunities for professional growth and development.

  • A collaborative and inclusive work environment.


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