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.
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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.