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.
