10 Dec, 2020

Senior Manager Process Engineering, Continuous Manufacturing

  • Thermo Fisher Scientific
  • Greenville, NC, USA
Process Engineer   Biochemicals / Pharmaceuticals Plastics & Manufacturing

Job Description

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?

Continuous Manufacturing Sr. Process Engineer will lead a cross functional 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. The Sr. Process Engineer will be accountable for decisions on design, staffing and ensuring technical solutions will meet the business requirements.

What will you do?

Technical

  • Evaluate, recommend, implement, and commission continuous equipment and instrumentation and systems for the development and commercial operations within a continuous manufacturing environment
  • Test, troubleshoot and optimize continuous manufacturing process technology for oral solid dosage forms
  • Create/approve documentation for User Requirement Specifications, 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, Automation and Validation departments in support of development projects to provide optimal continuous manufacturing processes
  • May act as project manager and/or primary SME for continuous manufacturing related capital projects
  • Define aspects of engineering 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
  • Manage and develop a small team of process and automation engineers supporting continuous manufacturing

How will you get here?

Education

  • Minimum required education in chemical/mechanical/pharmaceutical engineering/science or related field. Masters Degree with 5+ years of relevant experience or Ph.D. degree with 2+ years of relevant experience

Experience

  • 5+ years of applied/relevant work experience in modern control theory, and systems optimization
  • Ph.D. preferred with 2+ years of applied/relevant work experience in modern control theory, continuous process modeling, and systems optimization
  • Application of continuous manufacturing processes for solid dosage manufacture is preferred
  • 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.
  • Cross functional project management

Knowledge, Skills, Abilities

  • 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 to detect inconsistencies, determine relative importance, and solve complex technical situations.
  • Project management
  • Talent development

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 EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


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