Staff Process Engineer - Upstream
Thermo Fisher Scientific

Job Info

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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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