Principal Engineer​/Principal MFG Scientist, Mfg Sciences

Role Summary

As a Principal Engineer / Principal Manufacturing Scientist within the Manufacturing Sciences team, you will provide technical expertise for clinical and commercial manufacturing campaigns at our Parenteral Facility Drug Product site. Leverage your knowledge in fill/finish, visual inspection, and packaging, serving as a lead and subject matter expert in investigations and project implementation. By driving process improvements and technology transfers, you will contribute to the success of manufacturing operations, enhance the capabilities of our manufacturing personnel, and ensure regulatory compliance.

You will collaborate with cross-functional teams, interface with regulatory agencies, and support continuous advancement in manufacturing processes.

• Lead investigations and act as the point of contact for the Manufacturing Technical Organization.
• Develop an in-depth training program to enhance process understanding for seasoned manufacturing personnel.
• Analyze data related to unit operations and establish a platform for trending programs.
• Manage technical projects that provide value to the RTP Pharma site, ensuring process improvements and transfers.
• Communicate continuous improvement activities, deviations, technology transfer deliverable schedules, and metrics to management and partner departments.
• Facilitate meetings with various stakeholders and report program statuses to management through effective project management.
• Actively pursue and implement technical improvement projects through the global change control process.
• Interface with regulatory agencies during inspections, presenting technical reports and operational activities.

• Required:
  
  Bachelors degree in Engineering or relevant scientific/technical discipline with at least 10 years of relevant experience OR Masters degree with at least 8 years of direct experience OR Ph.D. with at least 6 years of direct experience.
• Required:
  
  In-depth knowledge in technical understanding of Parenteral Filling Operations (e.g., Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
• Required:
  
  Ability to work independently and collaboratively in large cross-functional groups.
• Required:
  
  Effective communication and project management skills for leadership in technology transfer projects.
• Required:
  
  Proficiency in analyzing scientific datasets with strong analytical and written skills.
• Required:
  
  Ability to lead and work well in individual and leadership roles.
• Required:
  
  Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification requirements.
• Preferred:
  Experience with regulatory inspections and technical report management.
• Preferred:
  Strong background in data analysis for process improvements.
• Preferred:
  Ability to develop and implement training programs for manufacturing personnel.
• Preferred:
  Six Sigma Black Belt Certification is strongly preferred.

• Project management and leadership in technology transfer projects.
• Data analysis and interpretation of complex scientific datasets.
• Strong written and verbal communication skills.
• Collaboration across cross-functional teams and with regulatory agencies.

• Bachelors degree in Engineering or relevant scientific/technical discipline with at least 10 years of experience; OR Masters degree with at least 8 years; OR Ph.D. with at least 6 years.