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Director, Continuous Manufacturing Process Engineer

Company: Thermo Fisher Scientific Inc.
Location: Durham
Posted on: September 13, 2020

Job Description:

Director, Continuous Manufacturing Process Engineer When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

The Director, Continuous Manufacturing Process Engineer will be a part of a team of technical professionals dedicated to designing, commissioning, and implementing continuous manufacturing methodologies to support Pharma Services drug product development pipeline from formulation development up through commercial launch and supply.

What will you do?

Methods

Execute scientific studies and designed experiments in the optimization and control of process unit operations and applying learnings to the continuous manufacturing platform

Perform advanced data analysis, process control model development, and apply findings to the continuous processing platform

Provide expertise in the selection, application, and optimization and troubleshooting real-time analytics (RTA) to support drug product continuous manufacturing platform

Provide expertise in data management, mining, and process monitoring related to PAT

Support the creation, maintenance, update, modification and lifecycle of in-line and at-line real time analytics models

Evaluate, recommend, and liaise with industry and academic collaborative groups engaged in pharmaceutical continuous manufacturing

Technical

Evaluate, recommend, implement, and commission continuous equipment and instrumentation and systems for the development of continuous manufacturing

Develop, scale-up, technology transfer, and optimize continuous manufacturing processes for new solid dosage products and formulations. Identify implementation opportunities and strategies for the transfer of existing batch processes to continuous manufacturing

Create/approve documentation for User System Requirements, Factory Acceptance Testing and Site Acceptance Testing; installation, operations, and performance (IQ/OQ/PQ) of continuous manufacturing equipment, instrumentation, and facilities

Write technical reports and/or presentations relevant to drug product continuous processing activities and present to various levels of management

Business and Organization

Interface with PDS, Engineering, Operations, Quality, and Validation departments in support of development projects to provide optimal continuous manufacturing processes

May act as project manager for continuous manufacturing related projects

Define aspects of project scope and use project management skills to schedule, track progress, and make adjustments to project timelines

Develop budgetary and schedule estimates for the requirements of projects

How will you get here?

Education

Masters or PhD degree in chemical/mechanical/pharmaceutical engineering/science or related field

Experience

5+ years of applied/relevant work experience in modern control theory, continuous process modeling, and systems optimization

PhD with 2+ years of applied/relevant work experience in modern control theory, continuous process modeling, and systems optimization

Mathematical modeling and optimization software to solve practical problems

Implementation of industrial model-based process control & optimization is required

Application of continuous manufacturing processes for solid dosage manufacture is required

The selected candidate will have a solid background in process engineering and how it applies to pharmaceutical process development and design, Process Analytical Technologies (PAT), Quality by Design (QbD), and multivariate analysis

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

Applied understanding of statistical principles like PCA/PLS, correlation and regression analysis as it applies to continuous pharmaceutical manufacturing processes

Proficient knowledge of FDA regulatory requirements

Create detailed technical reports

Effectively present detailed technical information and respond to technical questions. Knowledge of pharmaceutical business processes and equipment

Review SOPs and work instructions

Analyze data detecting inconsistencies, determining relative importance, and to solve complex technical situations based on data

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

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Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Keywords: Thermo Fisher Scientific Inc., Durham , Director, Continuous Manufacturing Process Engineer, Other , Durham, North Carolina

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